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Novek Ec 10mg Gastro-Resistant Capsules Hard

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Omeprazole 10mg and 20mg gastro-resistant capsules, hard

1.3.1 - Proposed Package Leaflet / clean version

PACKAGE LEAFLET PACKAGING

PACKAGING HDPE BOTTLES

PACKAGE LEAFLET: INFORMATION FOR THE USER

NOVEK EC 10 mg, gastro-resistant capsules, hard NOVEK EC 20 mg, gastro-resistant capsules, hard

Omeprazole

Read all of this leaflet carefully before you start taking this medicine.

- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Novek EC is and what it is used for

2. Before you take Novek EC

3. How to take Novek EC

4. Possible side effects

5. How to store Novek EC

6. Further information

1. WHAT NOVEK EC IS AND WHAT IT IS USED FOR

Novek EC 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.

Novek EC is used for treating the following conditions:

In adults:

• ‘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.

• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).

• Ulcers which are infected with bacteria called ‘Helicobacter pylori ’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

• Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Novek EC can also be used to stop ulcers from forming if you are taking NSAIDs.

• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and > 10 kg

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.

2. BEFORE YOU TAKE NOVEK EC Do not take Novek EC

• if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Novek EC.

• if you are allergic to medicines containing other proton pump inhibitors (eg pantoprazole, 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 Novek EC.

Take special care with Novek EC

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

• You lose a lot of weight for no reason and have problems swallowing.

• You get stomach pain or indigestion.

• 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 severe liver problems.

Taking a proton pump inhibitor like Novek EC, 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 Novek EC 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.

Taking other medicines

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 Novek EC can affect the way some medicines work and some medicines can have an effect on Novek EC.

Do not take Novek EC 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:

• Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus)

• 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 Novek EC

• 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 Novek EC

• Rifampicin (used to treat tuberculosis)

• Atazanavir (used to treat HIV infection)

• Tacrolimus (in cases of organ transplantation)

• St John’s wort (Hypericumperforatum) (used to treat mild depression)

• Cilostazol (used to treat intermittent claudication)

• Saquinavir (used to treat HIV infection)

• Clopidogrel (used to prevent blood clots (thrombi))

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

Taking Novek EC with food and drink

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

Pregnancy and breast-feeding

Before taking Novek EC, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can take Novek EC during this time.

Your doctor will decide whether you can take Novek EC if you are breastfeeding.

Driving and using machines

Novek EC 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.

Important information about some of the ingredients of Novek EC

This medicine contains sucrose and propyl-p-hydroxybenzoate (E216) and methyl-p-hydroxy benzoate (E218) (parahydroxybenzoates):

- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product;

- Parahydroxybenzoates may cause allergic reactions (possibly delayed).

3. HOW TO TAKE NOVEK EC

Always take Novek EC exactly as your doctor has told you. You should 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 usual doses are given below.

Adults:

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

• If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if your gullet has not yet healed.

• The usual dose once the gullet has healed is 10 mg once a day.

• If your gullet has not been damaged, the usual dose is 10 mg once a day.

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

• The usual dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.

• If the ulcer do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):

• The usual dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.

• If the ulcer do not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.

To prevent the duodenal and stomach ulcers from coming back:

• The usual 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 usual dose is 20 mg once a day.

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

• The usual dose is 20 mg Novek EC twice a day for one week.

• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

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

• The usual dose is 60 mg daily.

• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.

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 Novek EC. 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 Novek EC. 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 capsules in the morning.

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

• Swallow your capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules 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 capsules

• If you or your child have trouble swallowing the capsules:

- Open the capsules and swallow the contents directly with half a glass of water or put the contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.

- Always stir the mixture just before drinking it (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. The solid pieces contain the medicine - do not chew or crush them.

If you take more Novek EC than you should

If you take more Novek EC than prescribed by your doctor, talk to your doctor or pharmacist straight away.

If you forget to take Novek EC

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 forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Novek EC can cause side effects, although not everybody gets them.

If you notice any of the following rare but serious side effects, stop taking Novek EC 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.

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:	frequency cannot be estimated from the available data

Other side effects include:

Common side effects

• Headache.

• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).

• Feeling sick (nausea) or being sick (vomiting).

Uncommon side effects

• 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 of the hip, wrist or spine.

Rare side effects

• 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

• 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.

• Hypomagnesaemia. If you are on Novek EC 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, 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.

Novek EC 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.

Do not be concerned by this list of possible side effects. You may not get any of them.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE NOVEK EC

Do not store above 30 °C. Store in the original package and keep the bottle tightly closed, in order to protect from light and moisture.

Do not take your capsules after the expiry date which is stated on the carton label and bottle label after “EXP”. The expiry date refers to the last day of that month.

Use within 3 months after first opening of the bottle.

Keep out of the reach and sight of children.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Novek EC contains

- The active substance is: omeprazole. Each capsule contains 10 mg or 20 mg omeprazole.

- The other ingredients are: sucrose and maize starch, hypromellose, dimeticone emulsion [propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol sorbitan monolaureate, octylphenoxy polyethoxy ethanol and propylene glycol], polysorbate 80,

mannitol, diacetylated monoglycerides, talc, methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate, stearoyl macrogolglycerides, gelatin, titanium dioxide (E171), shellac, black iron oxide (E172). The 10 mg strength capsules also contain yellow iron oxide (E172).

What Novek EC looks like and contents of the pack

NOVEK EC is a gastro-resistant capsule, hard and comes in two strengths containing 10 mg or 20 mg of omeprazole. Each strength of capsule is a different colour:

- 10 mg capsules are yellow/white with imprint “10 mg”;

- 20 mg capsules are white with imprint “20 mg”.

NOVEK EC comes in a blister containing 7, 14, 15, 28, 30, 50, 60, 90 or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

BOTICALIA Limited

UNIT 27 ACTON PARK, THE VALE,

LONDON, W3 7QE.

UNITED KINGDOM

Manufacturer

Ethypharm, 17/21, rue Saint-Matthieu, 78550 Houdan, France Or

Ethypharm, Chemin de la Poudriere, 76120 Grand-Quevilly, France Or

Ethypharm, Z.I de Saint-Arnoult, 28170 Chateauneuf-en-Thymerais, France Or

Toll Manufacturing Services, SL, C/Aragoneses 2, 28108 Alcobendas (Madrid), Spain Or

Rottendorf Pharma GmbH, Ostenfelder Str 51-61, 59320 Ennigerloh, Germany Or

PNG Gerolymatos S.A. (Plant A'), 13 Asklipiou Street, GR-14568 Kryoneri, Greece

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

United-Kingdom: Novek EC 10mg and 20mg gastro-resistant capsule, hard

Greece: Novek EC 10mg and 20mg gastro-resistant capsule, hard

Italy: Omeprazolo ratiopharm 10mg and 20mg capsule rigide gastroresistenti

Spain: Novek 20 mg Capsulas gastro-resistentes

This leaflet was last approved in .

PACKAGE LEAFLET

PACKAGING

PA-Aluminium-PVC/Aluminium foil blister packs