Safety profile of UPSA Portfolio

UPSA MEDICINAL PRODUCTS

Safety Information Summaries

start

Version date : 18-Mar-2024 / Ref. number : T-20-019

1. GOALS

Goals

Knowledge of the UPSA portfolio (drugs)

Knowledge about the safety specifications

Understand the risk associated of each drug

index

Our portfolio by indication

occasional insomnia

COLD AND FLU

PAIN AND FEVER

FATIGUE

digestive disorders

sour stomach and intestinal bloating

1. PAIN ANF FEVER - SUMMARY

Pain and Fever

• PARACETAMOL (oral and rectal formulations)
• PARACETAMOL / VITAMIN C
• PARACETAMOL / CODEINE
• PARACETAMOL / CAFFEINE
• PARACETAMOL / PSEUDOEPHEDRINE
• ASPIRIN / VITAMIN C
• NIFLUMIC ACID / MORNIFLUMATE
• ASPIRIN

8 products

1. PAIN AND FEVER - PARACETAMOL

Paracetamol

DRUG-CLASS: Analgesic and antipyretic with weak anti-inflammatory activity (ATC code: N02BE01)

INDICATION(S):

• Symptomatic treatment of mild to moderate pain and fever
• Short-term treatment of fever in adults and children
• Symptomatic treatment of arthritis pain.

MULTIPLE STRENGTH(S) / FORMULATION(S) ROUTE OF ADMINISTRATION: Oral or rectal FIRST UPSA MARKETING AUTHORISATION: 28 MAY 1971 COUNTRIES: more than 50 countries APPROVAL PROCEDURE(S) IN EU: National/MRP/DCP

+INFO

2. Safety Specification - PARACETAMOL

Safety Specification

RSI: CCDS for paracetamol oral formulations dated 9 Feb 2023 and CCDS for paracetamol rectal formulations dated 15 Feb 2023 RMP: version 3.0 dated 6 July 2022 Next PSUR/PBRER (EURD list): 13Y-PBRER (DLP: 21 December 2025)

+INFO

3. Safety CONCERNS - PARACETAMOL

Safety Concerns - Paracetamol

Important potential risks

Missing information

Important identified risks

1. Hepatotoxicity
2. Hypersensitivity including severe cutaneous adverse reactions
3. Drug interaction with anticoagulants

None

1. Well-controlled clinical trials in pregnant and lactating women

According to last version of RMP (v.4.0), all safety concerns have been removed. So, all safety concerns to be replaced by "None"

1. PAIN AND FEVER - PARACETAMOL VIT C

Paracetamol Vitamin C

DRUG-CLASS: Paracetamol is an analgesic and antipyretic with weak anti-inflammatory activity. Vitamin C is an essential water-soluble vitamin (ATC code: N02BE51).

INDICATION(S):

• Adults and children weighing 15 kg and more for:
• Symptomatic treatment of mild to moderate pain and fever
• Short-term treatment of fever.

STRENGTH(S) / FORMULATION(S): Effervescent tablet (330 mg/200 mg), Effervescent tablet (500 mg/200 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 8 MAY 1957 COUNTRIES: more than 30 countries APPROVAL PROCEDURE(S) IN EU: National

2. Safety Specification - PARACETAMOL VIT C

Safety Specification

RSI: CCDS for paracetamol/vitamin C oral formulations dated 15 Nov 2021 RMP: not applicable Next PSUR/PBRER (EURD list): 23Y-PBRER (DLP: 01 January 2035)

+INFO

3. Safety CONCERNS - PARACETAMOL VIT C

Safety Concerns - Paracetamol Vit C

Important potential risks

Missing information

Important identified risks

1. Hepatotoxicity
2. Hypersensitivity including severe cutaneous adverse reactions
3. Drug interaction with anticoagulants

None

1. Well-controlled clinical trials in pregnant and lactating women

As there is no RMP for Paracetamol/Vit C and all safety concerns have been removed from RMP Paracetamol only, to be discussed if this slide needs to be aligned on the slide for paracetamol only.

1. PAIN AND FEVER - PARACETAMOL CODEINE

Paracetamol Codeine

DRUG-CLASS: Paracetamol is an analgesic and antipyretic with weak anti-inflammatory activity. Codeine phosphate is an opioid derivative with analgesic and antitussive activity (ATC code: N02BE51).

INDICATION(S):

• Symptomatic treatment of moderate to severe pain unresponsive to nonopioids used alone

STRENGTH(S) / FORMULATION(S): Effervescent tablet (500 mg/ 30 mg), Film-coated tablet (500 mg/ 30 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 8 MAY 1957 COUNTRIES: more than 25 countries APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - PARACETAMOL CODEINE

Safety Specification

RSI: CCDS for paracetamol/codeine oral formulations dated 23 May 2022 RMP: Version 1.1 dated 05 Sep 2019 Next PSUR/PBRER (EURD list): 13Y-PBRER (DLP: 01 September 2025)

+INFO

3. Safety CONCERNS - PARACETAMOL CODEINE

Safety Concerns - Paracetamol Codeine

Important potential risks

Missing information

Important identified risks

1. Hepatotoxicity
2. Hypersensitivity including severe cutaneous adverse reactions
3. Drug interaction with anticoagulants
4. Respiratory depression (codeine)
5. Addiction and dependence (codeine)

None

1. Well-controlled clinical trials in pregnant and lactating women

1. PAIN AND FEVER - PARACETAMOL CAFFEINE

Paracetamol Caffeine

DRUG-CLASS: Paracetamol is an analgesic and antipyretic with weak anti-inflammatory activity. Caffeine is a centra nervous system stimulant (ATC code: N02BE51).

INDICATION(S):

• Symptomatic treatment of mild to moderate pain and/or fever in adults and children aged 15 years or over.

STRENGTH(S) / FORMULATION(S): Film-coated tablet (500 mg/ 65 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 4 MAY 2018 COUNTRIES: more than 15 countries APPROVAL PROCEDURE(S) IN EU: National/DCP

+INFO

2. Safety Specification - PARACETAMOL CAFFEINE

Safety Specification

RSI: Belgian and French SmPC for paracetamol/caffeine dated respectively 27 September 2023 and 22 May 2023 RMP: Version 1.2 dated 20 July 2021 Next PSUR/PBRER (EURD list): 13Y-PBRER (DLP: 24 June 2025)

+INFO

3. Safety CONCERNS - PARACETAMOL CAFFEINE

Safety Concerns - Paracetamol Caffeine

Important potential risks

Missing information

Important identified risks

1. Hepatotoxicity
2. Hypersensitivity including severe cutaneous adverse reactions
3. Drug interaction with anticoagulants
4. Respiratory depression (codeine)
5. Addiction and dependence (codeine)

1. Risk of lower birth weight and spontaneous abortion associated with caffeine consumption during pregnancy (caffeine)
2. Stimulating effect in breastfed infants (caffeine)
3. Excitement or hallucinations during concomitant use of caffeine with enoxacin (caffeine)

1. Well-controlled clinical trials in pregnant and lactating women

According to last version of RMP for paracetamol/caffeine, there is no safety concerns for this association. Therefore, all sections should be populated with "None".

1. PAIN AND FEVER - PARACETAMOL PSEUDOEPHEDRINEE

Paracetamol Pseudoephedrine

DRUG-CLASS: Paracetamol is an analgesic and antipyretic with weak anti-inflammatory activity. Pseudoephedrine is an upper respiratory tract decongestant with direct and indirect sympathomimetic activity (ATC code: N02BE52).

INDICATION(S):

• Symptomatic treatment of nasal congestion with fever and/or pain such as sore throat or headache in common cold or influenza like conditions in ADULTS and ADOLESCENTS over 12 years of age.

STRENGTH(S) / FORMULATION(S): Effervescent tablet (500 mg/60 mg), Granules in sachet (500 mg/60 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 2 December 2015 COUNTRIES: 1 country (Italy) APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - PARACETAMOL PSEUDOEPHEDRINEE

Safety Specification

RSI: Italian SmPC for paracetamol/pseudoephedrine dated July 2022 RMP: V 1.0 dated 06 July 2023 Last PSUR/PBRER (EURD list): 5Y-PBRER (DLP: 28 June 2023)

+INFO

3. Safety CONCERNS - Paracetamol Pseudoephedrine

Safety Concerns - Paracetamol Pseudoephedrine

Important potential risks

Missing information

Important identified risks

1. Paracetamol Important identified risks
2. Cerebrovascular accidents (Pseudoephedrine)
3. Cardiovascular events (hypertension, arrhythmias, coronary artery disease) (Pseudoephedrine)
4. Ischemic optic neuropathy (Pseudoephedrine)
5. Ischemic colitis (Pseudoephedrine)
6. Drug interaction with monoamine oxidase inhibitors (MAIOs) and sympathomimetic drugs (Pseudoephedrine)
7. Breastfeeding (Pseudoephedrine)

1. Well-controlled clinical trials in pregnant (Paracetamol and pseudoephedrine)
2. Use in children under 12 years of age

none

According to last version of RMP for paracetamol/pseudo, there is no safety concerns for this association. Therefore, all sections should be populated with "None".

1. PAIN AND FEVER - ASPIRINE VIT C

Aspirin Vit C

DRUG-CLASS: Acetylsalicylic acid is a nonselective, nonsteroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic and antiplatelet activity. Vitamin C is an essential water-soluble vitamin (ATC code N02BA51).

INDICATION(S):

• This formulation is reserved for adults and children from 20 kg (aged from around 6 years) for the symptomatic treatment of mild to moderate pain and/or febrile conditions.

STRENGTH(S) / FORMULATION(S): Effervescent tablet (330 mg/200 mg), effervescent tablet (500 mg/200 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 24 July 1962 COUNTRIES: 30 countries APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - ASPIRINE VIT C

Safety Specification

RSI: French SmPC for aspirin/vitamin C dated 7 June 2021 RMP: none Next PSUR/PBRER (EURD list): 23Y-PBRER (DLP: 4 February 2035)

+INFO

3. Safety CONCERNS - ASPIRINE VIT C

Safety Concerns - Aspirine Vit C

Important identified risks

Important potential risks

1. Severe Gastrointestinal (GI) complications (including ulceration and perforation)
2. Major haemorrhages including GI haemorrhage and intracranial haemorrhage
3. Severe hypersensitivity including anaphylactic reactions
4. Maternal, neonatal, and foetal toxicity with exposure during the 3rd trimester of pregnancy
5. Disturbance in renal function homeostasis in patients with renal, hepatic, or cardiac insufficiency
6. Clinically significant drug interactions
7. Haemolysis in patients with G-6-PD deficiency
8. Severe skin reactions, including Stevens–Johnson syndrome (SJS) /toxic epidermal necrolysis (TEN)

Reye’s syndrome

Missing information

none

1. PAIN AND FEVER - NIFLUMIC ACID / MORNIFLUMATE

NIFLUMIC ACID / MORNIFLUMATE

DRUG-CLASS: Niflumic acid is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic activity (ATC code M01AX02 and M02AA17).

INDICATION(S): Capsules and suppositories (for adult and children older than 12 years-old)

• short-term, symptomatic relief of pain due to acute episodes of arthrosis and nonarticular rheumatism (eg, tendinitis, bursitis)
• short-term, symptomatic relief of pain due to inflammatory conditions in the fields of ear, nose and throat (ENT), and stomatology
• long-term, symptomatic relief of pain due to chronic, inflammatory, rheumatic disorders (eg, rheumatoid arthritis)

Suppositories (for paediatric use / at least 6 months of age)

• short-term, symptomatic relief of pain due to inflammatory conditions in the fields of ENT and stomatology
• long-term, symptomatic relief of pain due to juvenile osteoarthritis

Gel for topical use (in adults and children older than 12 years-old)

• for short-term, symptomatic relief of pain due to superficial tendinitis / sprains and contusions

+INFO

1. PAIN AND FEVER - NIFLUMIC ACID / MORNIFLUMATE

NIFLUMIC ACID / MORNIFLUMATE

DRUG-CLASS: Niflumic acid is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic activity (ATC code M01AX02 and M02AA17).

STRENGTH(S) / FORMULATION(S): Effervescent tablet (330 mg/200 mg), effervescent tablet (500 mg/200 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 24 July 1962 COUNTRIES: 30 countries APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - NIFLUMIC ACID/MORNIFLUMATE

Safety Specification

RSI: CCDS for niflumic acid and morniflumate dated 19 January 2012 RMP: none Next PSUR/PBRER (EURD list): Niflumic acid: 3Y-PBRER (DLP: 31 December 2024) / Morniflumate: 13Y-PBRER (DLP: 01 January 2025)

+INFO

3. Safety CONCERNS - Paracetamol Pseudoephedrine

Safety Concerns - Paracetamol Pseudoephedrine

Important potential risks

Missing information

Important identified risks

1. Serious gastrointestinal disorders, e.g., haemorrhage, ulceration, perforation
2. Hypersensitivity
3. Renal insufficiency
4. Cardiovascular and cerebrovascular events (hypertension, cardiac failure, and arterial thrombotic events including myocardial infarction and stroke)

none

1. Liver function abnormality
2. Increased toxicity of co-administered drugs (methotrexate and lithium)
3. Skin effects including serious reactions
4. Use during pregnancy

1. PAIN AND FEVER - ASPIRINE

Aspirine (Acetylsalicylic acid)

DRUG-CLASS: Acetylsalicylic acid is a nonselective, nonsteroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic and antiplatelet activity (ATC code N02BA01).

INDICATION(S):

• Symptomatic treatment of mild-to-moderate pain and/or febrile conditions.
• Chronic inflammatory rheumatism, acute articular rheumatism in children.
• Symptomatic treatment of inflammatory rheumatism in adults.

STRENGTH(S) / FORMULATION(S): Effervescent tablet (1000 mg), effervescent tablet (500 mg), effervescent tablet (325 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 24 July 1962 COUNTRIES: more than 20 countries (Marketing stop in France) APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - ASPIRINE

Safety Specification

RSI: French and Belgian SmPC for aspirin dated respectively 7 June 2021 and 17 March 2022 RMP: none Next PSUR/PBRER (EURD list): 8Y-PBRER (DLP: 01/02/2030)

+INFO

3. Safety CONCERNS - ASPIRINE

Safety Concerns - Aspirine

Important identified risks

1. Severe Gastrointestinal (GI) complications (including ulceration and perforation)
2. Major haemorrhages including GI haemorrhage and intracranial haemorrhage
3. Severe hypersensitivity including anaphylactic reactions
4. Maternal, neonatal, and foetal toxicity with exposure during the 3rd trimester of pregnancy
5. Disturbance in renal function homeostasis in patients with renal, hepatic, or cardiac insufficiency
6. Clinically significant drug interactions
7. Haemolysis in patients with G-6-PD deficiency
8. Severe skin reactions, including Stevens–Johnson syndrome (SJS) /toxic epidermal necrolysis (TEN)

Important potential risks

Reye’s syndrome

Missing information

none

1. PAIN ANF FEVER

Cold and Flu

• PARACETAMOL / VITAMIN C / PHENIRAMINE MALEATE
• PARACETAMOL / CHLORPHENAMINE MALEATE
• ACETYLCYSTEINE
• CARBOCISTEINE
• OXOMEMAZINE

5 products

1. PAIN AND FEVER - PARACETAMOL / VITAMIN C / PHENIRAMINE MALEATEE

Paracetamol/Pheniramine/Vit C

DRUG-CLASS: Paracetamol is an analgesic and antipyretic with weak anti-inflammatory activity. Vitamin C is an essential water-soluble vitamin and Pheniramine is an antihistaminic (ATC code: R05X).

INDICATION(S):

• It is indicated in adults and children (from 15 years of age) in symptomatic treatment in the course of colds, rhinitis, rhinopharyngitis and influenza-like conditions, of clear nasal discharge and lacrimation, sneezing, headaches and/or fever.

STRENGTH(S) / FORMULATION(S): Granules for oral solution (500 mg/200 mg/25 mg); granules for oral solution (280 mg/100 mg/10 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 06 June 1980 COUNTRIES: more than 40 countries APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - PARACETAMOL / VITAMIN C / PHENIRAMINE MALEATE

Safety Specification

RSI: CCDS for paracetamol/vit C/pheniramine dated 05 May 2022 RMP: Version 2.0 dated 19 Dec 2018 Next PSUR/PBRER (EURD list): 13Y-PBRER (DLP: 01 September 2025) Next PBRER (Russia): 3Y-PBRER (DLP: 07 MAY 2025)

+INFO

3. Safety CONCERNS - PARACETAMOL / VITAMIN C / PHENIRAMINE MALEATE

Safety Concerns - Paracetamol/Pheniramine/Vit C

Important potential risks

Missing information

Important identified risks

1. Hepatotoxicity (Paracetamol)
2. Hypersensitivity including severe cutaneous adverse reactions (Paracetamol)
3. Drug interaction with anticoagulants (Paracetamol)
4. Exacerbated sedation (pheniramine maleate)

None

1. Well-controlled clinical trials in pregnant and lactating women (Paracetamol/ Vitamin C/Pheniramine)

1. COLD AND FLU - PARACETAMOL / CHLORPHENAMINE MALEATE

Paracetamol/Chlorphenamine maleate

DRUG-CLASS: Paracetamol is an analgesic and antipyretic with weak anti-inflammatory activity. Chlorphenamine is a first-generation H1 histamine receptor inhibitor (ATC code: N02BE01).

INDICATION(S):

• For treatment, during the course of colds, rhinitis, rhinopharyngitis and flu-like conditions in adults and children aged over 15 years: of clear nasal discharge and watering of the eyes, of sneezing, of headaches and/or fever.

STRENGTH(S) / FORMULATION(S): Film coated tablet (500 mg/4 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 25-Apr-2018 COUNTRIES: less than 10 countries APPROVAL PROCEDURE(S) IN EU: National/MRP

+INFO

2. Safety Specification - PARACETAMOL / CHLORPHENAMINE MALEATE

Safety Specification

RSI: RSI for paracetamol/chlorpheniramine dated 20 July 2023 RMP: version 4.1 dated 15 February 2023 Next PSUR/PBRER (EURD list): Not applicable because well-established use

+INFO

3. Safety CONCERNS - PARACETAMOL / CHLORPHENAMINE MALEATE

Safety Concerns - Paracetamol/Chlorphenamine maleate

Important potential risks

Missing information

Important identified risks

1. Hepatotoxicity (Paracetamol)
2. Hypersensitivity including severe cutaneous adverse reactions (Paracetamol)
3. Drug interaction with anticoagulants (Paracetamol)
4. Exacerbated sedation (chlorpheniramine maleate)

None

1. Well-controlled clinical trials in pregnant and lactating women (Paracetamol and chlorpheniramine maleate)

According to last version of RMP for paracetamol/chlorphenamine, there is no safety concerns for this association. Therefore, all sections should be populated with "None".

1. COLD AND FLU - ACETYLCYSTEINE

ACETYLCYSTEINE

DRUG-CLASS: Acetylcysteine is a mucolytic mucomodulator (ATC code: R05CB01).

INDICATION(S):

• For treatment, during the course of colds, rhinitis, rhinopharyngitis and flu-like conditions in adults and children aged over 15 years: of clear nasal discharge and watering of the eyes, of sneezing, of headaches and/or fever.

STRENGTH(S) / FORMULATION(S): Powder for oral solution 200 mg ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 14 September 1963 COUNTRIES: more than 15 countries APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - ACETYLCYSTEINE

Safety Specification

RSI: French SmPC for acetylcysteine dated 8 December 2020 RMP: version 2.0 dated 9 November 2018 Last PSUR/PBRER (EURD list): 5Y-PBRER (DLP: 13 September 2023)

+INFO

3. Safety CONCERNS - ACETYCLYSTEINE

Safety Concerns - Acetylcysteine

Important potential risks

Missing information

Important identified risks

1. Severe hypersensitivity including anaphylactic shock
2. Respiratory tract congestion
3. Bronchospasm

None

1. Use in pregnant and lactating women

1. COLD AND FLU - CARBOCISTEINE

CARBOCISTEINE

DRUG-CLASS: Carbocisteine is a mucolytic type mucus modifier used for the treatment of bronchial secretion disorders, particularly in acute bronchial diseases (ATC code: R05CB03).

INDICATION(S):

• This medicinal product is indicated in adults in case of recent respiratory disease with difficult expectoration (difficulty clearing sputum).

STRENGTH(S) / FORMULATION(S): Oral solution in sachet (750 mg/10 mL), oral solution in bottle 5% ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 14 September 1963 COUNTRIES: 1 country (France) APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - CARBOCYSTEINE

Safety Specification

RSI: French SmPC for carbocisteine dated 13 July 2023 RMP: none Next PSUR/PBRER (EURD list): 13Y-PBRER (DLP: 14 September 2025) No safety concerns

+INFO

1. COLD AND FLU - OXOMEMAZINE

OXOMEMAZINE

DRUG-CLASS: Oxomemazine is an H1-antihistamine (ATC code: R06AD08).

INDICATION(S):

• symptomatic treatment of annoying non-productive coughs that occur specifically at night in adults and children above 2 years old.

STRENGTH(S) / FORMULATION(S): Oral solution in bottle (0.33 mg/mL) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 17-Mar-2015 COUNTRIES: 1 country (France) APPROVAL PROCEDURE(S) IN EU: National

Generic

+INFO

2. Safety Specification - OXOMEMAZInE

Safety Specification

RSI: French SmPC for oxomemazine dated 26 April 2022 RMP: none Next PSUR/PBRER (EURD list): 13Y-PBRER (DLP: 11 March 2025)

No safety concerns

+INFO

1. OCCASIONAL INSOMNIA - SUMMARY

Occasional insomnia

• DOXYLAMINE SUCCINATE

1 product

1. Occasional INSOMNIA - DOXYLAMINE SUCCINATEE

DOXYLAMINE SUCCINATE

DRUG-CLASS: Doxylamine is a first-generation H1-antihistamine (ATC code R06AA09).

INDICATION(S):

• Doxylamine is a first-generation H1-antihistamine (ATC code R06AA09).

STRENGTH(S) / FORMULATION(S): Film coated tablet (15 mg), Effervescent tablet (15 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 30-Jul-1974 COUNTRIES: more than 20 countries APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - DOXYLAmINE

Safety Specification

RSI: CCDS for doxylamine dated 23 May 2018 RMP: version 2.0 dated 2 March 2020 Next PSUR/PBRER (EURD list): 5Y-PBRER (DLP: 06/04/2028)

+INFO

3. Safety CONCERNS - DOXYLAMINE

Safety Concerns - Doxylamine

Important potential risks

Missing information

Important identified risks

1. Increase of anticholinergic effects due to interaction
2. Central nervous system (CNS) depression increased due to interaction with alcohol or other CNS depressants
3. Intentional overdose
4. Rhabdomyolysis (secondary to overdose)

None

1. Use in paediatric population

1. Sour stomach and intestinal bloating - SUMMARY

Sour stomach and intestinal bloating

1 product

• DIMETICONE

1. Sour Stomach and Intestinal bloating - DIMETICONE

DIMETICONE

DRUG-CLASS: Dimeticone is an antiflatulent (ATC code: A03AX13).

INDICATION(S):

• Symptomatic treatment of stomach pains and supplementary treatment for meteorism.

STRENGTH(S) / FORMULATION(S): Oral gel in tube (15 g), oral gel in sachet (2,25 g) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 11 January 1965 COUNTRIES: less than 10 countries APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - DIMETICONE

Safety Specification

RSI: French SmPC dated 9 December 2020 RMP: none Next PSUR/PBRER (EURD list): 13Y-PBRER (DLP: 30 April 2025)

+INFO

3. Safety CONCERNS - DIMETICONE

Safety Concerns - Dimeticone

Important potential risks

Missing information

Important identified risks

1. Allergic reactions

Hyperglycaemia

1. Effects of use during pregnancy and lactation

1. DIGESTIVE DISORDERS - SUMMARY

Digestive disorders

1 product

• BETAINE CITRATE

1. digestive disorders - BETAINE CITRATE

BETAINE CITRATE

DRUG-CLASS: Betaine is involved in the synthesis of phospholipids and has an action on gastric motility (ATC code: A16AA).

INDICATION(S):

• For treatment of dyspepsia disorders (slow digestion, bloating) in patients over 15 years.

STRENGTH(S) / FORMULATION(S): Effervescent tablet 2g ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 19 July 1976 COUNTRIES: more than 10 countries APPROVAL PROCEDURE(S) IN EU: National

+INFO

2. Safety Specification - BETAINE CItrATE

Safety Specification

RSI: French SmPC for betaine citrate dated 28 July 2020 RMP: none PSUR/PBRER (EURD list): Not applicable. Local French 3Y-PSUR (DLP: 18 July 2024)

+INFO

3. Safety CONCERNS - BETAINE CITRATE

Safety Concerns - Betaine Citrate

Important potential risks

Missing information

Important identified risks

1. Hypersensitivity reactions

None

1. Use in pediatric patients < 15 years of age
2. Exposure during pregnancy and lactation
3. Use in elderly population
4. Use in patients with renal and/or hepatic disease

1. FATIGUE - SUMMARY

Fatigue

1 product

• VITAMINE C (Ascorbic acid)

1. FATIGUE - VITAMIN C

VITAMIN C

DRUG-CLASS: Vitamin C is an essential water-soluble vitamin (ATC code: A11GA01).

under the food supplement (non-drug) status as soon as January 2023.

INDICATION(S):

• Temporary states of fatigue.

STRENGTH(S) / FORMULATION(S): Effervescent tablet (1000 mg), Chewable tablet (500 mg) ROUTE OF ADMINISTRATION: Oral FIRST UPSA MARKETING AUTHORISATION: 23 June 1981 COUNTRIES: more than 20 countries APPROVAL PROCEDURE(S) IN EU: National

+INFO

+INFO

2. Safety Specification - VITAMINE C

Safety Specification

RSI: French SmPC dated 9 November 2021 RMP: none Next PSUR/PBRER (EURD list): 13Y-PBRER (DLP: 25 February 2025)

No safety concerns

+INFO

Learning Unit completed

Good job!

HOME