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Omeprazol Pensa

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Document: Omeprazol Pensa gastro-resistant capsule, hard ENG PL change

Package leaflet: Information for the user


Omeprazol Pensa 10 mg gastro-resistantcapsules, hard

Omeprazol Pensa 20 mg gastro-resistantcapsules, hard

Omeprazol Pensa 40 mg gastro-resistantcapsules, hard


Omeprazole


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.


What is in this leaflet

1. What Omeprazol Pensa is and what it is used for

2. What you need to know before you take Omeprazol Pensa

3. How to take Omeprazol Pensa

4. Possible side effects

5. How to store Omeprazol Pensa

6. Contents of the pack and other information


What Omeprazol Pensa is and what it is used for


Omeprazol Pensa contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.


Omeprazol Pensa is used to treat the following conditions:

In adults:


In children:

Children over 1 year of age and ≥ 10 kg

Gastro-esophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.

In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.


Children and adolescents over 4 years of age

Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this

condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.


What you need to know before you take Omeprazol Pensa


Do not take Omeprazol Pensa

lansoprazole, rabeprazole, esomeprazole).

if you are taking a medicine containing nelfinavir (used for HIV infection)


If you are not sure, talk to your doctor or pharmacist before taking Omeprazol Pensa.


Warnings and precautions

Talk to your doctor or pharmacist before taking Omeprazol Pensa.

if you are due to have a specific blood test (Chromogranin A)


Omeprazol Pensa may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Omeprazol Pensa or while you are taking it, 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 Omeprazol Pensa. Remember to also mention any other

ill-effects like pain in your joints.


Taking a proton pump inhibitor like Omeprazol Pensa, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).


If you take Omeprazol Pensa on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.


Other medicines and Omeprazol Pensa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Omeprazol Pensa can affect the way some medicines work and some medicines can have an effect on Omeprazol Pensa.


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


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


If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazol Pensa to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.


Omeprazol Pensa with food and drink

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


Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide whether you can take Omeprazol Pensa during this time.


Your doctor will decide whether you can take Omeprazol Pensa if you are breastfeeding.


Driving and using machines

Omeprazol Pensa 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.


Omeprazol Pensa contains sucrose

Omeprazol Pensa gastro-resistant capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


How to take Omeprazol Pensa


Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


Your doctor will tell you how many capsules to take and how long to take them for. This will depend on your condition and how old you are.

The recommended doses are given below.


Adults:

To treat symptoms of GERD such as heartburn and acid regurgitation:


To treat ulcers in the upper part of the intestine (duodenal ulcer):


To treat ulcers in the stomach (gastric ulcer):


To prevent the duodenal and stomach ulcers from coming back:

The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.


To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The usual dose is 20 mg once a day for 4–8 weeks.


To prevent duodenal and stomach ulcers if you are taking NSAIDs:

The recommended dose is 20 mg once a day.


To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

metronidazole.


To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellisonsyndrome):


Use in children

To treat symptoms of GERD such as heartburn and acid regurgitation:

Children over 1 year of age and with a body weight of more than 10 kg may take Omeprazol Pensa. 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:


Taking this medicine


What to do if you or your child have trouble swallowing the capsules

If you or your child have trouble swallowing the capsules:

- Open the capsules and disperse the contents 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 30 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 Omeprazol Pensa than you should

If you think you have been given too much Omeprazol Pensa, talk to your doctor straight away.


If you forget to take Omeprazol Pensa

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.


Possible side effects


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 Omeprazol Pensa and contact a doctor immediately:


Side effects may occur with certain frequencies, which are defined as follows:

Very common:

affects more than 1 user in 10


Common:

affects 1 to 10 users in 100


Uncommon:


affects 1 to 10 users in 1,000


Rare:


affects 1 to 10 users in 10,000


Very rare:


affects less than 1 user in 10,000


Not known:


cannot be estimated from the available data



Other side effects include:

Common side effects


Uncommon side effects

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 of the hip, wrist or spine (if Omeprazol Pensa is used in high doses and over a long period of time).


Rare side effects

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

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.


Omeprazol Pensa 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.


Not known


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 or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


How to store Omeprazol Pensa


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 pack after EXP. The expiry date refers to the last day of that month.


Blister: Do not store above 30°C. Store in the original package, in order to protect from moisture.


Plastic jar: This medicinal product does not require any special temperature storage conditions.Keep the jar tightly closed, in order to protect from moisture.


Do not throw away any medicines wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.


Contents of the pack and other information


What Omeprazol Pensa contains


What Omeprazol Pensa looks like and contents of the pack

Description:

Omeprazol Pensa 10 mg: Opaque white capsules marked with “OM 10”. Contains white to light beige rounded granules.

Size number 4 capsules (approximately 0.7 x 1.2 cm).


Omeprazol Pensa 20 mg: Opaque white capsules marked with “OM 20”. Contains white to light beige rounded granules.

Size number 3 capsules (approximately 0.8 x 1.4 cm).


Omeprazol Pensa 40 mg: Opaque white capsules marked with “OM 40”. Contains white to light beige rounded granules.

Size number 1 capsules (approximately 1.0 x 1.7 cm).


Pack sizes:

Omeprazol Pensa 10 mg:

Blister: 7, 14, 28, 56 gastro-resistant capsules.

Plastic jars with screw cap containing desiccant: 16, 32, 100 (2 x50), 100 (1x100), 104, 105 gastro-resistant capsules.


Omeprazol Pensa 20 mg:

Blister: 7, 28, 56 gastro-resistant capsules.

Plastic jars with screw cap containing desiccant: 16, 32, 56, 100 (2 x50), 100 (1x100), 104 (2x52), 104 (1x104), 105, 500 gastro-resistant capsules.


Omeprazol Pensa 40 mg:

Blister: 7, 14, 28, 56 gastro-resistant capsules.

Plastic jars with screw cap containing desiccant: 16, 30, 32, 100 (2x50), 100 (1x100), 104, 105 gastro-resistant capsules.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pensa Pharma AB, Birger Jarlsgatan 22, 114 34 Stockholm, Sweden


Manufacturer

Laboratories Dr.Esteve S.A,Sant Martí s/n Polígono Industrial la Roca, 08107-Martorelles (Barcelona), Spain


This medicinal product is authorised in the Member States of the EEA under the following names:

Country:

Name of product:

SE, DK, FI, NO, IS:

Omeprazol Pensa

IE:

Omeprazole Pensa


This leaflet was last revised in2016-11-01.