Pyrocalm Control Peppermint Flavour 20 mg Gastro-Resistant Tablets

1. What Omeprazole tablets are and what they are used for
2. What you need to know before you take Omeprazole tablets
3. How to take Omeprazole tablets
4. Possible side effects
5. How to store Omeprazole tablets
6. Contents of the pack and other information
Further helpful information

• If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used for HIV infection).

Do not take Omeprazole tablets if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist before taking Omeprazole tablets.

Tell your doctor or pharmacist before taking this medicine, if:

• You are due to have a specific blood test (Chromogranin A)
• You are due to have an endoscopy or an urea breath test
• Your body does not absorb vitamin B12 (cobalamin) very well

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with Omeprazole tablets treatment. Stop using Omeprazole tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Do not take Omeprazole tablets for more than 14 days without consulting a doctor. If you do not experience relief, or if you experience a worsening of symptoms, consult your doctor.

Omeprazole tablets may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Omeprazole tablets or while you are taking them, talk to your doctor straight away:

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or signs of indigestion (such as nausea, fullness, bloating especially after food intake).
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).
• You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea.
• You have had previous gastric ulcer or gastrointestinal surgery.
• You are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
• You continuously suffer from indigestion or heartburn for 4 or more weeks.
• You have jaundice or severe liver disease.
• You are aged over 55 years with new or recently changed symptoms.
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazole tablets that reduces stomach acid.

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Omeprazole tablets. Remember to also mention any other ill-effects like pain in your joints.

Seek urgent medical attention if you experience chest pain with light-headedness, sweating, dizziness or shoulder pain with shortness of breath. This could be a sign of a serious condition with your heart.

When taking omeprazole, inflammation in your kidneys may occur. Signs and symptoms may include decreased volume of urine or blood in your urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report such signs to your doctor.

This medicine may affect the way that your body absorbs vitamin B12, particularly if you need to take it for a long time. Please contact your doctor if you notice any of the following symptoms, which could indicate low levels of Vitamin B12:

• Extreme tiredness or lack of energy
• Pins and needles
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Disturbed vision
• Problems with memory, confusion, depression

Do not take Omeprazole tablets if you do not have symptoms of reflux (e.g. heartburn or acid regurgitation).

This medicine should not be used by children and adolescents under 18 years of age.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because Omeprazole tablets can affect the way some medicines work and some medicines can have an effect on Omeprazole tablets.

Do not take Omeprazole tablets if you are taking a medicine containing nelfinavir (used to treat HIV infection).

You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots (thrombi)).

Do not take this medicine with other medicines that limit the amount of acid produced in your stomach such as other proton pump inhibitors (e.g. pantoprazole, rabeprazole or esomeprazole) or an H2 antagonist (e.g. ranitidine or famotidine).

You may take this medicine with antacids (e.g. alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate or combinations of these) if needed.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus)
• Clarithromycin (used to treat infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Omeprazole tablets
• Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Omeprazole tablets
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases of organ transplantation)
• St John’s wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily stop your Omeprazole treatment

You can take your tablets with food or on an empty stomach.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will decide whether you can take Omeprazole tablets during this time. There is no evidence that Omeprazole tablets have any effect on fertility.

Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

Your doctor will decide whether you can take Omeprazole tablets if you are breast-feeding.

Omeprazole tablets are not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.

Omeprazole tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Omeprazole tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

• It is recommended that you take your tablets in the morning.
• You can take your tablets with food or on an empty stomach.
• Swallow your tablets whole with half a glass of water.
• Do not chew or crush the tablets. This is because the tablets are coated with enteric coating which stops the medicine from being broken down by the acid in your stomach. It is important not to damage the tablets. The tablets release the active ingredient in the intestine, where it is absorbed by your body to give an effect.

If you take more Omeprazole tablets than recommended, talk to your doctor or pharmacist straight away. You may experience symptoms such as diarrhoea, stomach ache, feeling or being sick, dizziness, headache, depression, confusion and apathy (lack of motivation).

If you forget to take a dose, take it as soon as you remember it on the same day. Do not take a double dose to make up for a forgotten dose.

• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction). (rare)
• Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’. (very rare)
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems. (rare)

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

• Headache.
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
• Benign polyps in the stomach.

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
• Spinning feeling (vertigo).
• Changes in blood tests that check how the liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Generally feeling unwell and lacking energy.
• Fractures of the hip, wrist and spine.

Rare side effects (may affect up to 1 in 1,000 people)

• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Taste changes.
• Eyesight problems such as blurred vision.
• Suddenly feeling wheezy or short of breath (bronchospasm).
• Dry mouth.
• An inflammation of the inside of the mouth.
• An infection called "thrush" which can affect the gut and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people)

• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Erythema multiforme.
• Muscle weakness.
• Enlarged breasts in men.

Not Known (Frequency cannot be estimated from the available data)

• Inflammation in the gut (leading to diarrhoea).
• Hypomagnesaemia (low level of magnesium in the blood).
• Rash, possibly with pain in the joints.

Omeprazole tablets may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is omeprazole. Each tablet contains 20 mg of omeprazole.
• The other ingredients are lactose monohydrate, sodium starch glycolate, sodium stearyl fumarate, sodium stearate, hypromellose acetate succinate, blue colour (which contains hypromellose, titanium dioxide, triacetin and brilliant blue FCF (E133)), talc, peppermint flavour, triethyl citrate, levomenthol, monoethanolamine, sodium laurilsulfate, sucralose and traces of carnauba wax.

Pyrocalm Control Peppermint Flavour 20mg Gastro-Resistant Tablets are blue film coated capsule shaped tablets.

The pack contain blisters of 7 or 14 tablets.

Not all pack sizes may be marketed.

What are the symptoms of heartburn?

The normal symptoms of reflux are a painful sensation in the chest rising up to your throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Why do you get these symptoms?

Heartburn can be a result of eating too much, eating high fat food, eating too quickly and drinking lots of alcohol. You may notice that when you lie down your heartburn gets worse. If you are overweight or smoke you increase the chance of suffering from heartburn.

What can I do to help relieve my symptoms?

• Try to avoid spicy and fatty foods and large meals late before bedtime.
• Avoid fizzy drinks, coffee, chocolate and alcohol.
• Eat slowly and eat smaller portions.
• Try to lose weight.
• Stop smoking.

When should I seek advice or help?

• You should seek urgent medical advice if you experience chest pain with light-headedness, sweating, dizziness or shoulder pain with shortness of breath.
• If you experience any of the symptoms detailed in Section 2 of this leaflet and it advises you to talk to your doctor or pharmacist.
• If you are suffering from any of the side effects detailed in Section 4 which require medical attention.

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