Patient leaflet - Mezzopram 40 mg dispersible gastro-resistant tablets
What Mezzopram is and what it is used for 1
What you need to know before you take Mezzopram
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How to take Mezzopram
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Ref: V017: – Change in SmPC/PL/Labelling to align texts to the ref product + MHRA Request Use in Children and adolescents
To treat symptoms of GORD such as heartburn and acid regurgitation:
Children over 1 year of age and with a body weight of more than 10 kg may take Mezzopram. The dose for children is based on the child’s weight and the doctor will decide the correct dose.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
- Children aged over 4 years may take Mezzopram. The dose for children is based on the child’s weight and the doctor will decide the correct dose.
- Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.
Taking this medicine
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 contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.
What to do if you or your child have trouble swallowing the tablets
If you or your child have trouble swallowing the tablets: - Break the tablet and disperse it in a spoonful of water (non-fizzy), any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
- Always stir the mixture just before drinking (the mixture will not be clear). Then drink the mixture straight away or within 15 minutes.
- To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. Do not use milk or fizzy water. The solid pieces contain the medicine - do not chew or crush them.
If you take more Mezzopram than you should
If you take more Mezzopram than prescribed by your doctor, talk to your doctor or pharmacist straight away.
If you forget to take Mezzopram
If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Mezzopram
Do not stop taking Mezzopram without first talking to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
The 20 mg and 40 mg tablet can be divided into equal doses.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking Mezzopram and contact a doctor immediately:
- Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction)
- 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’.
- Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
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
- Fracture in the hip, wrist or 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
- Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing • 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
- Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness
- 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)
- Changes in blood count including agranulocytosis (lack of white blood cells)
- Aggression
- Seeing, feeling or hearing things that are not there (hallucinations)
- Severe liver problems leading to liver failure and inflammation of the brain
- Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Muscle weakness
- Enlarged breasts in men.
Not known (frequency cannot be estimated from the available data)
Inflammation in the gut (leading to diarrhoea). • If you are on Mezzopram for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also
lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
- Rash, possibly with pain in the joints.
Mezzopram 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer and inner pack after EXP. The expiry date refers to the last day of that month.
For HDPE containers, before first opening:
Do not store above 25°C.
For HDPE containers, after first opening:
Shelf life after first opening: 6 months
Do not store above 25ºC.
Keep the container tightly closed, in order to protect from moisture.
For Aluminium/aluminium blister:
Do not store above 25°C.
For Aclar/aluminium blister:
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Mezzopram contains
The active substance is omeprazole (as omeprazole magnesium).
Each gastro-resistant tablet contains 10 mg omeprazole. Each gastro-resistant tablet contains 20 mg omeprazole. Each gastro-resistant tablet contains 40 mg omeprazole.
The other ingredients are:
Tablet core:
Sucrose, maize starch, liquid glucose, copovidone, povidone, talc, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1), glycerol monostearate, propylene glycol, stearic acid, polysorbate 80, simeticone, cellulose microcrystalline, macrogol 6000, crospovidone, silica colloidal anhydrous, magnesium stearate.
Tablet coating:
Hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron oxide, red (E172). Only for Mezzopram 10 mg and Mezzopram 40 mg: Iron oxide, yellow (E172).
What Mezzopram look like and contents of the pack
Mezzopram 10 mg Dispersible Gastro-resistant Tablets: Light pink oval film-coated tablet (11.2 x 5.8 mm).
Mezzopram 20 mg Dispersible Gastro-resistant Tablets Pink, oval film-coated tablet with a breaking notch on both sides. The tablet can be divided into equal doses (14.2 x 7.2 mm).
Mezzopram 40 mg Dispersible Gastro-resistant Tablets Reddish oval film-coated tablet with a score line on both sides. The tablet can be divided into equal doses (18.2 x 9.0 mm).
Pack sizes:
Mezzopram is available in blister packs with 5, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 90, 98, 100 gastro-resistant tablets and in containers with 7, 14, 15, 28, 30, 56, 98, 100 gastro-resistant tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.,Trimlini 2 D, 9220 Lendava, Slovenia LEK S.A., Ul. Podlipie 16 C, 95 010 Strykow, Poland LEK S.A., Ul. Domaniewska 50, 02-672 Warszawa, Poland
This leaflet was last revised in 03/2018.
The following information is intended for healthcare professionals only:
Stomach tube administration for doctors:
If the patient is unable to swallow, the tablets can be dissolved in still water and administered via a stomach tube. It is important to ensure that the suitability of the selected syringe and tube is carefully verified.
Administration via a stomach tube
- 1. Put the tablet into an appropriate syringe and fill the syringe with approximately 25 ml water and approximately 5 ml air. For some tubes, dispersion in 50 ml water is needed to prevent the pellets from clogging the tube.
- 2. Immediately shake the syringe for approximately 2 minutes to disperse the tablet.
- 3. Hold the syringe with the tip up and check that the tip has not clogged.
- 4. Attach the syringe to the tube whilst maintaining the above position.
- 5. Shake the syringe and position it with the tip pointing down. Immediately inject 5-10 ml into the tube. Invert the syringe after injection and shake it. Keep the syringe tip pointed upward as this will avoid clogging.
- 6. Turn the syringe with the tip down and immediately inject another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.
- 7.
Fill the syringe with 25 ml water and 5 ml air and repeat step 5 if necessary to wash down any sediment left in the syringe. Some tubes will require 50 ml water.
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Possible side effects
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How to store Mezzopram
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Contents of the pack and other information 6
Ref: V017: – Change in SmPC/PL/Labelling to align texts to the ref product + MHRA Request