Leaflet FOSFAT DE CODEINA SINTOFARM 15mg tablets

Product code:
W01411002
Quantity:
30
Indicated for:
pain; cough
Route of administration:
oral
Substance:
codeine (opioid analgesic)
ATC
R05DA04 — Respiratory system | Cough suppressants, excl. combinations with expectorants | Opium alkaloids and derivatives

Precautions:

Driving impairment

Driving impairment

This medicine may affect your ability to drive or use machines.

Dizziness / vertigo

Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Dependence / abuse

Dependence / abuse

This medicine may cause dependence or be misused.

Respiratory depression

Respiratory depression

May slow breathing, especially with alcohol or sedatives.

Avoid alcohol

Avoid alcohol

Avoid alcohol during treatment.

Major drug interactions

Major drug interactions

This medicine may have important interactions with other medicines.

Breastfeeding warning

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Pregnancy warning

Use during pregnancy only on medical advice.

Elderly warning

Elderly warning

Older people may have an increased risk of side effects.

Withdrawal / do not stop abruptly

Withdrawal / do not stop abruptly

Do not stop treatment abruptly without medical advice.

Drowsiness / sedation

Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Codeine is an opioid analgesic used to treat mild to moderate pain, cough, and sometimes diarrhea. It is often combined with other pain relievers, such as paracetamol or ibuprofen, to enhance its analgesic effect.

Codeine works by binding to opioid receptors in the central nervous system, reducing the perception of pain and suppressing the cough reflex. It is available in tablet, capsule, syrup, or oral solution forms.

Side effects may include drowsiness, dizziness, constipation, nausea, or vomiting. In rare cases, it can cause respiratory depression, especially at high doses or in sensitive individuals. Prolonged use may lead to dependence. It is contraindicated in children under 12 years, breastfeeding women, and patients with severe respiratory insufficiency.

General data about FOSFAT DE CODEINA SINTOFARM 15mg

Substance:
codeine
Date of latest medicines list:
01-06-2026
Product code:
W01411002
Concentration:
15mg
Pharmaceutical form:
tablets
Quantity:
30
Product type:
Generic medicine
Price:
7.85 RON
Prescription status:
TAB3 — Medicines dispensed with a special medical prescription for psychotropic substances, green in color.

Marketing authorisation

Manufacturer:
SINTOFARM S.A. - ROMANIA
Holder:
SINTOFARM S.A. - ROMANIA
Number:
8515/2016/01
Shelf life:
3 years

Compensation lists for FOSFAT DE CODEINA SINTOFARM 15mg Sintofarm

A - Sublist A with 90% discount from the reference price

Price
7.85 RON
Copayment
7.06 RON
Patient
0.79 RON

G10 (C1) - Leukemias, lymphomas and bone marrow aplasia, tumors

Price
7.85 RON
Copayment
7.85 RON
Patient
0.00 RON

GX (C1) - GENERIC (used in compensation list, C1, for another diagnosis)

Price
7.85 RON
Copayment
7.85 RON
Patient
0.00 RON