Patient Leaflet Updated 19-Jul-2021 | Dexcel Pharma Ltd
Pyrocalm Control 20mg Gastro-Resistant Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pyrocalm Control® 20mg Gastro-Resistant Tablets
(Referred to as Pyrocalm Control Tablets throughout this leaflet)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without prescription. However, you still need to take Pyrocalm Control Tablets carefully to get the best results from them.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
What is in this leaflet:
1. What Pyrocalm Control Tablets are and what they are used for
2. What you need to know before you take Pyrocalm Control Tablets
3. How to take Pyrocalm Control Tablets
4. Possible side effects
5. How to store Pyrocalm Control Tablets
6. Contents of the pack and other information
Further helpful information
1. WHAT PYROCALM CONTROL TABLETS ARE AND WHAT THEY ARE USED FOR
This medicine contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. It works by reducing the amount of acid that your stomach produces.
The tablets are used in adults for the short-term treatment of reflux symptoms (for example, heartburn, acid regurgitation).
Reflux is the backflow of acid from the stomach into the gullet “foodpipe”, which may become inflamed and painful. This may cause you symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
This medicine is not meant to bring immediate relief. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYROCALM CONTROL TABLETS
Do not take Pyrocalm Control Tablets
Do not take Pyrocalm Control Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Tell your doctor before taking this medicine, if:
Do not take this medicine 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.
This medicine may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking these tablets or while you are taking them, talk to your doctor straight away:
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 this medicine. 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.
Do not take this medicine if you do not have symptoms of reflux (e.g. heartburn or acid regurgitation).
Children and adolescents: This medicine should not be used by children and adolescents under 18 years of age.
Other medicines and Pyrocalm Control Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because this medicine can affect the way some medicines work and some medicines can have an effect on these tablets.
Do not take this medicine 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:
Pyrocalm Control Tablets with food and drink
You can take your tablets with food or on an empty stomach.
Pregnancy, breast-feeding and fertility
Before taking this medicine, tell your doctor or pharmacist if you are pregnant or trying to get pregnant. Your doctor will decide whether you can take these tablets during this time. Your doctor will decide whether you can take this medicine if you are breast-feeding. There is no evidence that this medicine has any effect on fertility.
Driving and using machines
This medicine is 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.
Pyrocalm Control Tablets contain Lactose
This medicine contains 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.
Pyrocalm Control Tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
3. HOW TO TAKE PYROCALM CONTROL TABLETS
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one 20 mg tablet once a day for up to 14 days. Contact your doctor if you are not free from symptoms after this period.
It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Do not take more than the recommended dose (one 20mg tablet a day) even if you don’t feel an improvement immediately.
When your reflux symptoms have gone completely you should stop taking this medicine.
Taking this medicine
If you take more Pyrocalm Control Tablets than you should
If you take more 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 Pyrocalm Control Tablets
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pyrocalm Control Tablets can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking this medicine and contact a doctor immediately:
This medicine 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.
Other side effects include:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Not Known (Frequency cannot be estimated from the available data)
Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
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 at: 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.
5. HOW TO STORE PYROCALM CONTROL TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pyrocalm Control Tablets contain
The active substance is omeprazole. Pyrocalm Control Tablets contain 20 mg of omeprazole. The other ingredients are lactose monohydrate, sodium starch glycolate, sodium stearyl fumarate, sodium stearate, hypromellose acetate succinate, brownish pink colour (which contains propylene glycol, titanium dioxide (E171), red iron oxide (E172), hypromellose and yellow iron oxide (E172)), talc, triethyl citrate, monoethanolamine, sodium lauryl sulfate and traces of carnauba wax.
What Pyrocalm Control Tablets look like and contents of the pack
Pyrocalm Control 20 mg Gastro-Resistant Tablets are brownish-pink film coated capsule shaped tablets.
Blisters of 7, 14 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
This leaflet was last revised in April 2021.
Further Helpful Information
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?
When should I seek advice or help?
7, Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
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+44 (0) 1748 828 784
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