TANTUM VERDE

TANTUM VERDE 1.5 mg/ml spray for oral use

Important notes (mandatory information)

Omeprazole-ratiopharm SK 20 mg gastro-resistant hard capsules. Areas of application: is used in adults for the short-term treatment of reflux symptoms (e.g. heartburn, acid reflux). Warning: Contains sucrose!

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazole-ratiopharm SK 20 mg gastro-resistant hard capsules
Active ingredient: Omeprazole

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 14 days, contact your doctor.

What this leaflet contains

1. WHAT IS OMEPRAZOLE-RATIOPHARM SK 20 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING OMEPRAZOLE-RATIOPHARM SK 20 MG?
3. HOW TO TAKE OMEPRAZOLE-RATIOPHARM SK 20 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD OMEPRAZOLE-RATIOPHARM SK 20 MG BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS OMEPRAZOLE-RATIOPHARM SK 20 MG AND WHAT IS IT USED FOR?

Omeprazole-ratiopharm SK 20 mg contains the active ingredient omeprazole. It belongs to a group of medicines called "proton pump inhibitors". These work by reducing the amount of acid your stomach produces. Omeprazole-ratiopharm SK 20 mg is used in adults for the short-term treatment of reflux symptoms (e.g. heartburn, acid reflux). Reflux is the backflow of acid from the stomach into the oesophagus, which can become inflamed and cause pain. This can cause you to experience symptoms such as a burning sensation in the chest that rises up to the throat (heartburn) and a sour taste in the mouth (acid reflux). It may be necessary to take the gastro-resistant hard capsule for 2 - 3 consecutive days to achieve an improvement in symptoms.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING OMEPRAZOLE-RATIOPHARM SK 20 MG?

Omeprazole-ratiopharm SK 20 mg must not be taken:

• if you are allergic (hypersensitive) 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 (for an HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking Omeprazole-ratiopharm SK 20 mg.

Warnings and precautions

Do not take Omeprazole-ratiopharm SK 20 mg for longer than 14 days without consulting your doctor. If your symptoms do not improve or if your symptoms worsen, see your doctor. Please talk to your doctor or pharmacist before taking Omeprazole-ratiopharm SK 20 mg if you have ever experienced skin reactions as a result of treatment with a medicine comparable to Omeprazole-ratiopharm SK 20 mg, which also reduces stomach acid. If you develop a skin rash, especially in areas exposed to the sun, tell your doctor immediately as you may need to stop taking Omeprazole-ratiopharm SK 20 mg. Do not forget to mention any other harmful effects such as joint pain. Omeprazole-ratiopharm SK 20 mg can mask the signs of other illnesses.

Therefore, talk to your doctor immediately if any of the following apply to you before or during treatment with Omeprazole-ratiopharm SK 20 mg:

• You lose a lot of weight for no apparent reason and have difficulty swallowing.
• You get stomach pain or indigestion.
• You vomit food or blood.
• You pass black stools (blood in the stool).
• You suffer from severe or persistent diarrhoea. Omeprazole is associated with a small increased risk of infectious diarrhoea.
• You have had a stomach ulcer or surgery on your stomach or intestines in the past.
• You have been receiving continuous symptomatic treatment for indigestion or heartburn for 4 or more weeks.
• You have been suffering from persistent indigestion or heartburn for 4 or more weeks.
• You have jaundice or severe liver disease.
• You are over 55 years old and have new or recently changed symptoms.

Patients should not take omeprazole as a preventative measure.

Taking Omeprazole-ratiopharm SK 20 mg with other medicines

Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. This is important because Omeprazole-ratiopharm SK 20 mg can affect the way some medicines work and some medicines can have an effect on how Omeprazole-ratiopharm SK 20 mg works. Do not take Omeprazole-ratiopharm SK 20 mg if you are using a medicine containing nelfinavir (for the treatment of an HIV infection). You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots [clots]).

Please 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)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, to relax muscles or for epilepsy)
• Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Omeprazole-ratiopharm SK 20 mg
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor may need to monitor you when you start or stop taking Omeprazole-ratiopharm SK 20 mg
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat an HIV infection)
• Tacrolimus (in the case of organ transplants)
• St. John's wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat so-called intermittent claudication)
• Saquinavir (used to treat an HIV infection)
• Clopidogrel (used to prevent blood clots [clots])
• Erlotinib (used to treat cancer)
• Methotrexate (a medicine that is used in high doses in chemotherapy to treat cancer), if you are taking methotrexate in high doses, your doctor may temporarily discontinue your treatment with Omeprazole-ratiopharm SK 20 mg.

Taking Omeprazole-ratiopharm SK 20 mg with food and drink

You can take your gastro-resistant hard capsule with food or on an empty stomach.

Pregnancy and breast-feeding

Tell your doctor or pharmacist before taking Omeprazole ratiopharm SK 20 mg if you are pregnant or trying to become pregnant. Your doctor will decide whether you can take Omeprazole-ratiopharm SK 20 mg during this time. Your doctor will decide whether you can take Omeprazole-ratiopharm SK 20 mg if you are breast-feeding.

Driving and using machines

Omeprazole-ratiopharm SK 20 mg is unlikely to affect your ability to drive or operate tools or machines. Side effects such as dizziness and visual disturbances may occur (see 4. "What side effects are possible?"). You should not drive or operate machinery if you are affected.

Omeprazole-ratiopharm SK 20 mg contains sucrose

Please only take Omeprazole-ratiopharm SK 20 mg after consulting your doctor or pharmacist if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE OMEPRAZOLE-RATIOPHARM SK 20 MG?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The usual dose is one 20 mg gastro-resistant hard capsule once a day for 14 days. Tell your doctor if you are not symptom-free after this period. It may be necessary to take the gastro-resistant hard capsule for 2 - 3 consecutive days to achieve an improvement in symptoms.

Method of administration

It is recommended that you take your gastro-resistant hard capsule in the morning. You can take your gastro-resistant hard capsule with food or on an empty stomach. Swallow your gastro-resistant hard capsule whole with half a glass of water. Do not chew or crush the gastro-resistant hard capsule, as it contains coated micropellets that prevent the medicine from being broken down by the acid in the stomach. It is important that the micropellets are not damaged. These micropellets contain the active ingredient omeprazole and are coated with a gastro-resistant coating that protects them from being broken down during passage through the stomach. The micropellets release the active ingredient in the intestine, where it is absorbed by your body to take effect.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:

• Open the capsule and swallow the contents immediately with half a glass of water.
• You can also put the contents of the capsule in a glass with an acidic fruit juice (e.g. apple, orange or pineapple), applesauce or natural yoghurt. Always stir the mixture immediately before taking it. Then take the liquid immediately or within 30 minutes.
• To make sure you have taken all of the medicine, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine - they must not be chewed or crushed.
• The capsule can also be sucked and the solid particles then swallowed with half a glass of water. The solid particles must not be chewed or crushed.

If you take more Omeprazole-ratiopharm SK 20 mg than you should

If you have taken more Omeprazole-ratiopharm SK 20 mg than recommended, talk to your doctor or pharmacist immediately.

If you forget to take Omeprazole-ratiopharm SK 20 mg

If you forget to take a dose, take it as soon as you remember. 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.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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 Omeprazole-ratiopharm SK 20 mg and contact a doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. Serious blistering and bleeding of the lips, eyes, mouth, nose and genitals may also occur. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellow skin, dark urine and tiredness may be signs of liver problems.

Other side effects are

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

• Headache.
• Effects on your stomach or gut: diarrhoea, abdominal pain, constipation, flatulence (flatulence).
• Nausea or vomiting.

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

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling like "pins and needles", drowsiness.
• Vertigo (vertigo).
• Altered blood test results that check how the liver is working.
• Rash, hives (urticaria) and itchy skin.
• General malaise and lack of drive.

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

• Blood problems, such as a decrease in the number of white blood cells or platelets. This can cause weakness, bruising or make it more likely that you will get an infection.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
• Low sodium levels in the blood. This can lead to weakness, nausea (vomiting) and cramps.
• Feeling of excitement, confusion, depression.
• Changes in taste.
• Visual disturbances such as blurred vision.
• Sudden feeling of wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• An infection known as "thrush" that can affect the gut and is caused by a fungus.
• Liver problems, including jaundice, which can lead to yellowing of the skin, darkening of the urine and tiredness.
• Hair loss (alopecia).
• Skin rash from sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Changes in the blood count including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling and hearing things that are not there (hallucinations).
• Severe liver problems that can lead to liver failure and brain inflammation.
• Sudden onset of severe skin rash or blistering or peeling of the skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.

Unknown frequencies (frequency cannot be estimated from the available data):

• Rash, possibly associated with joint pain.
• Inflammation of the gut (leading to diarrhoea).
• Low magnesium levels in the blood (hypomagnesaemia); low magnesium levels can lead to a decrease in calcium levels in the blood.

In very rare cases, Omeprazole-ratiopharm SK 20 mg can affect the white blood cells, leading to an 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 difficulty urinating, you must see 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 inform your doctor about your current medicine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD OMEPRAZOLE-RATIOPHARM SK 20 MG BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister packs. The expiry date refers to the last day of the month indicated. Do not store above 25°C. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.