Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Gavilast Heartburn and Indigestion 75mg Film-coated tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ranitidine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What you need to know before you take it
e Gavilast Heartburn and | Indigestion 75 mg Film-coated tablets
How to take it
Gavilast Heartburn and Indigestion 75 mg Film-coated ' tablets
Store in the original package in order to protect from light.
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medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Gavilast Heartburn and Indigestion 75 mg Film-coated tablets Ranitidine Hydrochloride
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Possible side effects
'These measures will help protect the environment. GB CONTENTS OF THE PACK AND OTHER INFORMATION
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medicines and Gavilast Heartburn and Indigestion 75 mg '
Film-coated tablets:
'Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. This is because these tablets can affect the way some other medicines work. Also some other medicines can affect the way these tablets work.
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In particular tell your doctor or pharmacist if you are taking any of the following medicines: '° Blood thinning medicines e.g warfarin
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'Taking Gavilast Heartburn and Indigestion 75 mg Film-coated
tablets with food and drink
These tablets may be taken before or after meals, as soon as you have symptoms. Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine. 'This product should only be used during pregnancy and breast-feeding if considered essential.
Driving and using machines: These tablets have no known effects on the ability to drive or operate machinery.
El HOW TO TAKE GAVILAST HEARTBURN AND INDIGESTION 75 MG FILM-COATED TABLETS Adults (including the elderly) and children 16 years of age and
'over:
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Swallow one tablet whole with a glass of water as soon as you have symptoms. If symptoms persist for more than one hour or return, take} another tablet. Do not take more than two tablets in 24 hours. ! Do not take the tablets for more than 6 days is a row unless told to by' your doctor. Talk to your doctor if your symptoms get worse or persist; after 6 days treatment. Do not buy a second pack of this medicine without the advice of a
pharmacist
or doctor.
Not recommended for children under 16 years of age. if you take more Gavilast heartburn and indigestion 75 mg Film-coated tablets than you should: lf you have taken too much tell your doctor or hospital casualty department straight away. Take yourLe tablet pack with you. —-MoOl et oe ra LZ
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everybody gets them. Serious Allergic Reactions ! if you experience any of these reactions, stop taking the medicine and} seek medical help immediately: | Rash, itching or hives on the skin : Swelling of your face, lips, tongue or other parts of the body Chest pain, shortness of breath, wheezing or having trouble
breathing. Unexplained fever and feeling faint, especially when standing up.
ther Serious Side Effects Kidney problems, which can lead to back pain, fever, pain when passing urine, blood in the urine and changes in blood tests. Hepatitis (swollen liver). This can lead to feeling sick or being sick,
loss of appetite or generally feeling unwell, itching, fever, yellowing of the skin and eyes or dark coloured urine. e Pancreatitis, which can lead to severe abdominal pain, nausea, and: fever.
© Slow or irregular heartbeat If you experience any of the above side effects tell your doctor IMMEDIATELY or go to a casualty department at your nearest hospital. Other Possible side effects: Uncommon side effects (experienced by between 1 in 100 and 1 in 1 000 patients)
- Abdominal pain, constipation, nausea Rare side effects (experienced by between 1 in 1000 and 1 in 1 10000 patients)
ie Liver enzyme increases which may have an effect on some medical | tests fe Rise in plasma creatinine which may show up in kidney function ' tests
Skin rash
Very rare side effects (experienced by less than 1 in 10,000 patients) 'e Blood count changes, which could cause you to have an increased | risk of infection, or have a tendency to bruise or bleed more easily e Feeling confused, seeing or hearing unexplained things | (hallucinations)
Depression
'e Headache, dizziness or blurred vision ® Your small blood vessels can become swollen | (known as 'vasculitis'). r
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B POSSIBLE SIDE EFFECTS Like all medicines, these tablets can cause side effects, although not
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gelf-prescribed
#@ you have difficulty swallowing, persistent stomach pain or | unintended weight loss in association with symptoms of indigestion you are of middle age or older with new or recently changed ' symptoms of indigestion If any of these points apply to you, do not take this medicine until you have talked to your doctor. You may need to be given a different medicine or the dose may need to be changed.
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Film-coated tablets: 'Do not take a double dose to make up for forgotten individual doses. 'Take your next dose at the normal time. If you have any further questions on the use of this product ask your doctor or pharmacist.
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'1. What Gavilast Heartoum and Indigestion 75 mg Film-coated tablets: | are and what they are used for ;
Contents of the pack and other information
What Gavilast Heartburn and Indigestion 75 mg Film-coated tablets contain The active substance is ranitidine hydrochloride (75mg). The other ingredients are microcrystalline cellulose, magnesium stearate, hypromellose and titanium dioxide (E171). What these tablets look like and contents of the pack
These tablets are white, round and film coated with a "K" logo on one
side and 75 on the other. They come in blisters of 6 and 12 tablets.
PL 44041/0028
This package leaflet was last revised in October, 2016.
WHAT GAVILAST HEARTBURN AND INDIGESTION 75 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR This medicine contains Ranitidine. This is known as a histamine H2
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antagonist. It works by reducing the natural production of acid in the stomach. T hese tablets are used for the symptomatic relief of heartburn, indigestion, acid indigestion and too much acid in the stomach.
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WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVILAST HEARTBURN AND INDIGESTION 75 MG FILM-COATED TABLETS
Marketing Authorization Holder:
NOUMED LIFE SCIENCES LIMITED
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Noumed House, Shoppenhangers Road, Maidenhead, Berkshire, SL6 2RB, UK.
Do not take these tablets if: © you are hypersensitive (allergic) to ranitidine or any of the other ' ingredients of this product. See section 6 for ingredients. Warnings and precautions iTalk to your doctor or pharmacist before taking these tablets if you: 'e have a liver or kidney problems 'have had a stomach ulcer or a duodenal ulcer in the past @ have arare illness called porphyria 'e have breathing problems @ have weak immune system 'e suffer from diabetes @ you are under regular medical supervision for
Manufacturer: MEDREICH PLC
6mm6.5mm
Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail : [email protected] Distributed by : Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS
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Frequently asked questions about Gavilast Heartburn and Indigestion 75mg Film-coated tablets
How do I take Gavilast Heartburn and Indigestion 75mg Film-coated tablets?
Gavilast Heartburn and Indigestion 75mg Film-coated tablets comes as tablet containing 75mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Gavilast Heartburn and Indigestion 75mg Film-coated tablets?
The active substance in Gavilast Heartburn and Indigestion 75mg Film-coated tablets is ranitidine hydrochloride.
Are there equivalent medicines to Gavilast Heartburn and Indigestion 75mg Film-coated tablets?
Medicines with the same active substance, strength and form include: Boots Heartburn & Indigestion Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets (P). They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Gavilast Heartburn and Indigestion 75mg Film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Gavilast Heartburn and Indigestion 75mg Film-coated tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ranitidine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity.
4.2. Posology and method of administration
Route of Administration
Oral
Dosage
Adults (Including the Elderly) and children 16 years of age and older:
Swallow one Ranitidine 75 mg film-coated tablet whole, with a drink of water, as soon as you have symptoms. If symptoms persist for more than one hour or return, take another tablet.
Do not take more than two tablets in 24 hours.
Do not take the tablets for more than 6 days without the advice of a pharmacist or doctor.
Children under 16 years
Not recommended for children under 16 years of age
4.3. Contraindications
Ranitidine is contraindicated for people known to be hypersensitive to the drug or any ingredients of Ranitidine 75mg Film-coated tablets.
4.4. Special warnings and precautions for use
Treatment with a histamine H2-antagonist such as ranitidine may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition.
Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment. Ranitidine 75 mg film-coated tablet is not suitable for these patients without medical supervision
People taking non-steroidal anti-inflammatory drugs, especially those with a history of peptic ulcer and the elderly should not self-medicate with Ranitidine 75 mg film-coated tablet but seek their doctor's advice before use.
People with a history of porphyria should avoid use of the product.
Consumers will be advised not to purchase a second pack of tablets without the advice of a pharmacist of doctor.
The product is not indicated in the following people without seeking their doctor's advice:
• Patients with severe renal and/or hepatic impairment.
• Patients under regular medical supervision for other reasons.
• Patients taking medications either physician prescribed or self prescribed.
• Those with difficulty swallowing, persistent stomach pain or unintended weight loss in association with symptoms of indigestion.
• Those who are middle-aged or elderly with new or recently changed symptoms of indigestion.
In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia.
A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of H2 receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk increase of 1.82 (95% CI, 1.26–2.64).
4.5. Interaction with other medicinal products and other forms of interaction
Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.
Interactions occur by several mechanisms including:
1) Inhibition of cytochrome P450-linked mixed function oxygenase system:
Ranitidine at usual therapeutics doses does not potentiate the actions of drugs which are inactivated by this enzyme systems such as diazepam, lidocaine, phenytoin, propranol and theophylline.
There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.
2) Alteration of gastric pH:
The bioavailability of certain drugs may be affected. This can result in either an increase in absorption or a decrease in absorption.
4.6. Fertility, pregnancy and lactation
Ranitidine crosses the placenta but therapeutic doses administered to obstetric patients in labour or undergoing caesarean section have been without any adverse effect on labour, delivery or subsequent neonatal progress.
Like other over the counter drugs it should not be taken during pregnancy without consulting a doctor or pharmacist. It is also excreted in human breast milk and women who are breast-feeding will be advised to speak to their doctor before taking Ranitidine tablets.
4.7. Effects on ability to drive and use machines
No known effect. However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness, confusion and a blurred vision may occasionally occur when taking Ranitidine Tablets
4.8. Undesirable effects
The following convention has been utilised for the classification of undesirable effects: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (1/10,000).
Adverse event frequencies have been estimated from spontaneous reports from post-marketing data.
Hepatobiliary Disorders
Rare: Transient and reversible changes in liver function tests.
Very Rare: Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice. These were usually reversible.
Gastrointestinal Disorders
Very Rare: Acute pancreatitis and diarrhoea.
Uncommon: Abdominal pain, constipation, nausea. (these symptoms mostly improved during continued treatment).
Blood & Lymphatic System Disorders
Very rare: Blood count changes (Leucopenia and thrombocytopenia). These are usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or aplasia.
Immune System Disorders
Rare: Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension, chest pain)
Very rare: Anaphylactic shock.
These reactions have occasionally occurred after a single dose.
Cardiac Disorders
Very Rare: As with other H2 receptor antagonists bradycardia and A-V block.
Nervous System Disorders
Very rare: Headache (sometimes severe), dizziness and reversible involuntary movement disorders.
Psychiatric Disorders
Very rare: reversible mental confusion, depression and hallucinations
These have been reported, predominantly in severely ill and elderly patients.
Skin and Subcutaneous Tissue Disorders
Rare: Skin rash
Very rare: erythema multiforme and alopecia.
Musculoskeletal and Connective Tissue Disorders
Very rare: Musculoskeletal symptoms such as arthralgia and myalgia
Eye Disorders
Very Rare: Reversible blurred vision.
There have been reports of blurred vision, which is suggestive of a change of accommodation.
Vascular Disorders
Very Rare: Vasculitis
Renal and Urinary Disorders
Very Rare: Acute interstitial nephritis
Rare: Elevation of plasma creatinine (usually slight; normalised during continued treatment)
Reproductive System and Breast Disorders
Very Rare: Reversible impotence. Breast symptoms and conditions (such as gynaecomastia and galactorrhea)
Discontinuation of therapy may be necessary in order to establish the underlying cause.
No clinically significant interference with endocrine or gonadal function has been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If need be, the drug may be removed from the plasma by haemodialysis.
💬 Ask about this leaflet
Ask anything about Gavilast Heartburn and Indigestion 75mg Film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.