Ranitidine 75mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ranitidine 75 mg film-coated tablets ratiopharm
Active substance: ranitidine hydrochloride
For use in adults and adolescents from 16 years of age
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Ranitidine 75 mg tablets carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 14 days.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ranitidine 75 mg is and what it is used for
2. Before you take Ranitidine 75 mg
3. How to take Ranitidine 75 mg
4. Possible side effects
5. How to store Ranitidine 75 mg
6. Further information
1. WHAT RANITIDINE 75 MG IS AND WHAT IT IS USED FOR
Ranitidine 75 mg belongs to a group of medicines known as H2-receptor antagonists which reduce the amount of acid in your stomach.
Ranitidine 75 mg is used:
for the short-term, symptomatic treatment of heartburn.
2. BEFORE YOU TAKE RANITIDINE 75 MG
Do not take Ranitidine 75 mg:
• if you are allergic (hypersensitive) to ranitidine or any of the other ingredients of Ranitidine 75 mg. Ranitidine 75 mg may not be given to children under 16 years of age.
Take special care with Ranitidine 75 mg:
In the following situations or if any of the following symptoms occur, you must consult a doctor before you take Ranitidine 75 mg:
• if you have ever suffered from a stomach or intestinal ulcer.
• if you are inadvertently losing weight in association with existing indigestion problems.
• if you suffer from kidney or livery problems, or any other illness which requires regular medical supervision.
• if you suffer from any other illness, or are taking other medicines, that your doctor has prescribed or that you have bought yourself.
• if you you are taking painkillers such like non steroidal anti-inflammatory drugs (e.g. ibuprofen, Aspirin (acetyl-salicyclic acid)), especially if you are elderly, you should seek your doctor's advice before taking Ranitidine 75 mg.
• if you have a history of porphyria (a disease affecting the body's metabolism), as your doctor may decide that this medicine is not suitable for you.
• if you have ever had attacks of a disease which interfered with the production of red blood cells (porphyria, a severe illness whose symptoms include severe stomach pain, mental confusion and muscle weakness).
Treatment with Ranitidine 75 mg can mask the symptoms of more serious diseases, such as stomach cancer, and thus delay diagnosis of this disease. Therefore, it is important that your doctor has established that you do not have a malignant ulcer before starting treatment. This particularly applies to middle aged or older patients who have symptoms of indigestion that have recently appeared or changed.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription.
This particularly applies to the following medicines:
• procainamide, N-acetylprocainamide (medicines for the treatment of cardiac arrhythmias)
• theophylline (medicine for the treatment of asthma)
• glipizide (medicine for the treatment of diabetes)
• ketoconazole (medicine for the treatment of fungal infections).
You should always take medicines which reduce stomach acid (e.g. antacids, sucralfate)
2 hours after Ranitidine 75 mg, in order to prevent a reduction in the efficacy of Ranitidine 75 mg.
Taking Ranitidine 75 mg with alcohol:
Intake of Ranitidine 75 mg can enhance the effect of alcohol.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine.
During pregnancy you should not take Ranitidine 75 mg without asking your doctor.
The active substance passes into breast milk. You should avoid breast-feeding while taking Ranitidine 75 mg as this may cause stomach acid secretion disorders in your child.
Driving and using machines:
Ranitidine has basically no effect on the ability to drive or operate machinery. Nevertheless, rare side effects (see section 4. "Possible side effects") have been observed which may influence your ability to drive a vehicle or operate machinery (e.g. visual disturbances or dizziness). Furthermore, Ranitidine 75 mg enhances the effect of alcohol (see above "Taking Ranitidine 75 mg with food and drink").
3. HOW TO TAKE RANITIDINE 75 MG
Always take Ranitidine 75 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
|
Single dose |
Total daily dose | |
|
Adolescents over 16 years and above |
1 film-coated tablet (equivalent to 75 mg ranitidine) if complaints occur, during the day or night |
A maximum dose of 2 film-coated tablets (equivalent to 150 mg ranitidine) in 24 hours |
|
Children under 16 years of age |
Use in children under 16 years of age is not recommended. | |
Do not take Ranitidine 75 mg for longer than 14 days without your doctor's advice. You must contact a doctor if your symptoms worsen or do not improve after 14 days.
Method of administration:
Film-coated tablets for oral administration.
Please take the film-coated tablets with sufficient liquid (e.g. a glass of water).
If you have the impression that the effect of Ranitidine 75 mg is too strong or too weak, please talk to your doctor or pharmacist.
If you take more Ranitidine 75 mg than you should:
If intentional or accidental overdose occurs, you should immediately consult your doctor, who will undertake supportive treatment appropriate to the complaints.
If you forget to take Ranitidine 75 mg:
Do not take a double dose to make up for a forgotten tablet/dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ranitidine 75 mg can cause side effects, although not everybody gets them.
A few people can be allergic to some medicines. These reactions can occur following
administration of a single dose. If any of the following side effects come on soon after taking
these tablets, stop the tablets and tell your doctor immediately:
• hives, swelling of tongue, lips, face and throat (angioedema), fever, constriction of the airways, drop in blood pressure, inadequate blood flow through the body (circulatory shock), rise in certain blood cells (eosinophils), chest pain.
These side effects occur very rarely (less than 1 in 10,000 persons treated, including isolated reports).
Common (less than 1 in 10 persons treated)
• headache, dizziness
• nausea, constipation, diarrhoea
• fatigue
Uncommon (less than 1 in 100 persons treated)
• temporary changes to liver function values (these are usually detected by blood tests).
Rare (less than 1 in 1,000 persons treated)
• low levels of certain white blood cell (agranulocytosis) with fever, sore throat and ulceration in your mouth and throat. Contact your doctor, if you notice these symptoms.
• low levels of all blood cells (pancytopenia) which increases the risk of bleeding or bruising and makes infections more likely. Sometimes along with changes in bone marrow (bone marrow hypoplasia/ aplasia).
• temporary mental confusion, agitation, depression and hallucinations (seeing, feeling or hearing things that are not there). These side effects have mainly been observed in very ill or elderly patients.
• involuntary movement disorders.
• temporary blurred vision.
• heart rhythm disorders (increased heart rate or decreased heart rate, disturbances in the electrical signal that causes the heart to beat [AV block]).
• liver inflammation with or without jaundice (yellow colour of skin and white of eyes). These changes are usually temporary.
• Acute inflammation of the pancreas, which causes severe pain in the abdomen and back.
• a particular form of skin rash (erythema multiforme), hair loss, itching.
• joint disorders, muscle pain.
• a slight rise in one laboratory value (serum creatinine) (this is usually detected by blood tests).
• low sex drive (libido) and impotence in male patients.
Very rare (less than 1 in 10,000 persons treated, including isolated reports)
• temporary reduction in white blood cells (leucopenia), which makes infections more likely, or in blood platelets (thrombocytopenia), which increases the risk of bleeding or bruising.
• inflammation of the blood vessels, often with skin rash.
• breast formation and/or breast complaints in men. In some cases, complaints improved with continued ranitidine use.
• acute allergic reactions.
• inflammation of the kidneys (interstitial nephritis).
Countermeasures:
Your doctor will decide about any necessary countermeasures if you experience any side effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE RANITIDINE 75 MG
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister pack and carton. The expiry date refers to the last day of that month.
Do not store above 25 °C.
6. FURTHER INFORMATION
What Ranitidine 75 mg contains:
The active substance is ranitidine hydrochloride.
Each film-coated tablet contains 83.75 mg ranitidine hydrochloride, equivalent to 75 mg ranitidine. The other ingredients are:
microcrystalline cellulose, croscarmellose sodium, colloidal silica, magnesium stearate, talc, castor oil, hypromellose, titanium dioxide (E 171), red ferric oxide (E172).
What Ranitidine 75 mg looks like and contents of the pack:
Ranitidine 75 mg are light-pink, round film-coated tablets.
Ranitidine 75 mg is available in packs containing 6, 10, 12, 20, 24 and 28 film-coated tablets. Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Str. 3, D-89079 Ulm, Germany. www.ratiopharm.de
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Str. 3, D-89143 Blaubeuren, Germany.
This leaflet was last revised in July 2009.
Version code: Z0X