Sucralfate Doc Generici
Italy
Table of Contents
Patient Information Leaflet
SUCRALFATO DOC Generici 2 g granules for oral suspension
Sucralfate
Generic medicine
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What SUCRALFATO DOC Generici is and what it is used for
- What you need to know before taking SUCRALFATO DOC Generici
- How to take SUCRALFATO DOC Generici
- Possible side effects
- How to store SUCRALFATO DOC Generici
- Contents of the pack and other information
1. What SUCRALFATO DOC Generici is and what it is used for
SUCRALFATO DOC Generici contains the active substance sucralfate, which belongs to the group of
medicines used for the treatment of ulcers. It works by forming a protective barrier over the
lesions, preventing further irritation caused by stomach acids.
This medicine is used for the treatment of:
- stomach lesions (gastric ulcer), and intestinal lesions (duodenal ulcer);
- inflammation of the stomach, either as a transient or chronic condition (acute gastritis and chronic gastritis);
- stomach disorders caused by the use of anti-inflammatory medicines belonging to the NSAID group (non-steroidal anti-inflammatory drugs);
- inflammation of the esophagus due to the backflow of acidic fluids and/or food (reflux esophagitis).
2. What you need to know before taking SUCRALFATO DOC Generici
Do not take SUCRALFATO DOC Generici
- if you are allergic to sucralfate or to any of the other ingredients of this medicine (listed in section 6);
- if you have phenylketonuria, a condition characterized by high levels of phenylpyruvate in the urine and phenylalanine in the blood, as this medicine contains aspartame;
- if the patient is a premature infant.
Warnings and precautions
Talk to your doctor or pharmacist before taking SUCRALFATO DOC Generici.
Inform your doctor and use this medicine with caution, avoiding prolonged treatments in the following cases:
- if you have severe kidney problems (renal failure);
- if you are undergoing hemodialysis (mechanical blood filtration);
- if you have disorders affecting food movement through the digestive tract, as undigested material may accumulate (bezoars).
Children and adolescents
SUCRALFATO DOC Generici is not recommended for children under 14 years of age due to lack of data on safety and efficacy of this medicine.
Other medicines and SUCRALFATO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sucralfate may alter the effect of certain drugs, including:
- tetracyclines, ciprofloxacin and norfloxacin, medicines used to treat bacterial infections;
- ketoconazole, used to treat fungal infections;
- cimetidine and ranitidine, medicines used to treat stomach disorders such as gastritis and ulcers;
- digoxin, a medicine used to treat heart conditions;
- phenytoin, a medicine used in epilepsy;
- theophylline, a medicine used to treat respiratory disorders such as bronchial asthma.
Therefore, if you need to take any of the above-listed medicines, take them at least two hours before or after taking SUCRALFATO DOC Generici.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, use this medicine only if clearly needed and under medical supervision.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
SUCRALFATO DOC Generici contains aspartame and sorbitol
This medicine contains aspartame, a source of phenylalanine. It may be harmful if you have phenylketonuria (see section "Do not take SUCRALFATO DOC Generici").
This medicine contains sorbitol, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take SUCRALFATO DOC Generici
Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one sachet of granules twice daily, unless otherwise prescribed by your doctor.
Take the medicine on an empty stomach, after dissolving the granules in a small amount of water.
If you take more SUCRALFATO DOC Generici than you should
In case of accidental ingestion/overdose of SUCRALFATO DOC Generici, contact your doctor immediately or go to the nearest hospital.
If you forget to take SUCRALFATO DOC Generici
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions may occur:
- formation of accumulations of undigested material (bezoars);
- diarrhoea, flatulence, nausea, vomiting, feeling of stomach fullness;
- constipation, following prolonged treatment;
- dry mouth;
- skin rash and itching;
- dizziness;
- insomnia;
- headache;
- lower back pain;
- allergic-type reactions, including skin irritations (urticaria), swelling especially around mouth and eyes (angioedema), breathing difficulties, and allergic rhinitis.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system at the following website:
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store SUCRALFATO DOC Generici
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and to the medicine properly stored.
Store this medicine at a temperature not exceeding 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What SUCRALFATO DOC Generici contains
- The active substance is sucralfate. Each sachet contains 2 g of sucralfate.
- The other components are sorbitol, aspartame and orange flavour.
Description of the appearance of SUCRALFATO DOC Generici and pack contents
Pack containing 30 sachets of granulate.
Marketing Authorization Holder
DOC Generici Srl – Via Turati 40 – 20121 Milan
Manufacturer
Special Product’s Line S.r.l., Via Campobello, 15 – 00040 Pomezia (RM).
LA.FA.RE. S.r.l. – Via Sac. Benedetto Cozzolino 77 - 80056 Ercolano (NA)
Granulate division and final packaging:
Lamp S. Prospero S.p.A., Via della Pace, 25/A - 41030 S. Prospero S/Secchia (MO).