1. What is Omeprazole Pensavital and what is it used for?
Omeprazole Pensavital contains the active substance omeprazole. It belongs to a group of medicines called proton pump inhibitors. These medicines work by reducing the amount of acid produced by the stomach.
Omeprazole Pensavital is indicated in adults for the short-term treatment of reflux symptoms (e.g. heartburn, acid reflux).
Reflux occurs when acid rises from the stomach to the oesophagus, which can become inflamed and painful. This can cause symptoms such as a painful burning sensation in your chest which goes up to your throat (heartburn) and a sour taste in your mouth (acid regurgitation).
You may need to take the capsules for 2-3 consecutive days to improve your symptoms.
You should consult your doctor if your condition worsens does not improve after 14 days.
2. What you need to know before you start taking Omeprazole Pensavital
Do not take Omeprazole Pensavital
if you are allergic to omeprazole or any of the other ingredients in this medicine (listed in section 6).
if you are allergic to medicines containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
if you are taking a medicine containing nelfinavir (used for HIV infection).
Warnings and Precautions
Ask your doctor or pharmacist for advice before you start taking Omeprazole Pensavital.
Do not take Omeprazole Pensavital for more than 14 days without consulting your doctor. If you do not experience relief, or feel that your symptoms are getting worse, talk to your doctor.
Omeprazole Pensavital can mask the symptoms of other diseases. Therefore, tell your doctor immediately if you experience any of the following before you start taking Omeprazole Pensavital, or during your treatment:
Significant weight loss for no apparent reason, along with difficulties in swallowing.
Stomach pain or indigestion.
Vomiting food or blood.
Black (bloody) stools.
Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
You have a history of gastric ulcers or gastrointestinal surgery.
You have been receiving continued treatment to treat indigestion or heartburn for 4 weeks or more.
You have been suffering from continuous indigestion or heartburn for 4 weeks or more.
You have severe jaundice or liver disease.
You are over 55 years of age and your symptoms have recently changed or are new.
You have ever had a skin reaction after treatment with a medicine similar to Omeprazole Pensavital to reduce heartburn.
You are scheduled to have a specific blood test (Chromogranin A).
Inflammation of the kidney may occur when taking omeprazole. Signs and symptoms may include decreased amounts of urine, or blood in urine, and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should inform your doctor of any of these signs.
If you experience a skin rash, especially in areas of the skin which are exposed to the sun, speak to your doctor as soon as possible as it may be necessary to discontinue treatment with Omeprazole Pensavital. Remember to mention any other symptoms you may notice, such as joint pain.
Patients should not take omeprazole as a preventive medication.
Children and adolescents
Children and adolescents under 18 years of age should not take this medicine.
Taking Omeprazole Pensavital with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might need to take, any other medicines. This includes medicines obtained without a prescription. This is because Omeprazole Pensavital can affect the way some medicines work and some medicines can affect the functioning of Omeprazole Pensavital.
Do not take Omeprazole Pensavital if you are taking a medicine that contains nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:
Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections)
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 keep you under supervision when you start or stop taking Omeprazole Pensavital.
Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to keep you under supervision when you start or stop treatment with Omeprazole Pensavital.
Rifampicin (used to treat tuberculosis)
Atazanavir (used to treat HIV infection)
Tacrolimus (in organ transplant cases)
John's Wort (Hypericum perforatum) (used to treat mild depression)
Cilostazol (used to treat intermittent claudication)
Saquinavir (used to treat HIV infection)
Clopidogrel (used to prevent blood clots (thrombi))
Erlotinib (used to treat cancer)
Methotrexate (a chemotherapy drug used at high doses to treat cancer). If you are taking a high dose of methotrexate, your doctor will have to temporarily stop treatment with Omeprazole Pensavital.
Taking Omeprazole Pensavital with food and drink
See section 3.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medicine.
Omeprazole passes into breast milk but is unlikely to affect the baby when therapeutic doses are used. Your doctor will decide if you can take Omeprazole Pensavital while you are breastfeeding.
Driving and using machinery
Omeprazole is unlikely to affect your ability to drive or use tools and machinery. Side effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machinery.
Omeprazole Pensavital contains Sucrose
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicinal product.
This medicinal product contains less than 23 mg sodium (1 mmol) per capsule; that is, it is essentially "sodium-free".
3. How to take Omeprazole Pensavital
Always take Omeprazole Pensavital exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
The recommended dose is one 20 mg capsule, once daily for 14 days. Contact your doctor if the symptoms do not go away after this time.
You may need to take the capsules for 2-3 consecutive days to improve symptoms.
How to take this medicine
It is recommended that you take the capsules in the morning.
You can take the capsules with food or on an empty stomach.
Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated granules that prevent the medicine from being broken down by the action of stomach acid. It is important not to damage the granules. These granules contain omeprazole as the active ingredient and have an enteric coating that protects them from breaking open when they pass through the stomach.
The granules release the active substance into the gut, where it is absorbed by the body to produce its effect.
What to do if you have trouble swallowing the capsules
If you have trouble swallowing the capsules:
Open the capsules and swallow the contents directly with half a glass of water, or pour the contents into a glass of still water, acidic fruit juice (e. g. apple, orange or pineapple), or apple compote.
Always shake the mixture just before drinking it (the mixture will not be clear). Drink the mixture immediately or within 30 minutes.
To make sure you have taken all of the medicine, half fill the glass with water, rinse thoroughly, and drink the water. Do not use milk or sparkling water. The solid parts contain the medicinal product; do not chew or crush them.
Use in children and adolescents
Children and adolescents under 18 years of age should not take this medicine.
If you take more Omeprazole Pensavital than you should
If you have taken more Omeprazole Pensavital than prescribed by your doctor, tell your doctor or pharmacist immediately. You can also call the Toxicological Information Service, telephone number: 91 562 04 20, indicating the medicine and the quantity taken.
If you have forgotten to take Omeprazole Pensavital
If you miss a dose, take it as soon as you remember. However, if there is not much time left until your next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.
4. Possible side effects
As with all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following rare but serious side effects, stop taking Omeprazole Pensavital and consult your doctor immediately:
Sudden onset of wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
Redness of the skin with blistering or peeling. Severe blisters 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 colour, dark urine and tiredness, which can be symptoms of liver problems.
Other side effects are:
Common side effects (may affect up to 1 in 10 people)
Headache.
Effects on the stomach or intestine: diarrhoea, stomach pain, benign stomach polyps, constipation and gas (flatulence).
Nausea or vomiting.
Benign stomach polyps.
Uncommon side effects (may affect up to 1 in 100 people)
Swelling of the feet and ankles.
Sleep disorders (insomnia).
Dizziness, tingling sensation, drowsiness.
Feeling like everything is spinning (vertigo).
Changes in the results of blood tests used to check liver function.
Skin rash, hives and itching.
Feeling of general malaise and lack of energy.
Rare side effects (may affect up to 1 in 1,000 people)
Blood problems, such as a decrease in counts of white blood cells or platelets. This can cause weakness or bruising and increase the chance of getting infections.
Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever and wheezing.
Low sodium levels in the blood. This can lead to weakness, vomiting and cramping.
Agitation, confusion or depression.
Changes in sense of taste.
Visual problems, like blurred vision.
Sudden sensation of breathing difficulties (bronchospasm).
Dry mouth.
Inflammation inside the mouth.
An infection called candidiasis, that can affect the intestine and is caused by a fungus.
Liver problems, such as jaundice, which can cause yellow skin, dark urine, and tiredness.
Hair loss (alopecia).
Rash on the skin with exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
Severe kidney problems (interstitial nephritis).
Increased sweating.
Very rare side effects (these may affect up to 1 in 10,000 people)
Blood count disorders, such as agranulocytosis (lack of white blood cells).
Aggressiveness.
Seeing, feeling or hearing things that don't exist (hallucinations).
Severe liver problems that cause liver failure and brain inflammation.
Sudden onset of severe rash, blistering or peeling of the skin. This can be accompanied by high fever and joint pains (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Muscle weakness.
Increased breast size in men.
Low magnesium levels in the blood.
Unknown frequency (not possible to estimate from the available data)
Inflammation in the intestine (which causes diarrhoea).
Hypomagnesaemia.
Skin rash, possibly with joint pain.
In very rare cases, Omeprazole Pensavital can affect the white blood cells and cause immunodeficiency. If you have an infection with symptoms such as fever and your general condition is very deteriorated, or fever with symptoms of local infection, such as neck, throat or mouth pain or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a shortage of white blood cells (agranulocytosis). It is important that you provide medical staff with information about the medicine you are taking at that time.
Do not worry about this list of possible side effects. You may not experience any of them. If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Reporting side effects
If you experience any type of side effect, including any not mentioned in this leaflet, tell your doctor or pharmacist. You can also notify them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: www.notificaRAM.es.
You are helping to provide more information on the safety of this medicine when you report side effects.
5. How to store Omeprazole Pensavital
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.
Bottle: It does not require special storage conditions. Keep the bottle tightly closed in order to protect it from moisture.
Al/Al blister: Do not store above 25°C. Store in the original package in order to protect it from moisture.
Medicines should not be disposed of via waste water or household waste. All packaging and medicines that you no longer need should be disposed of in the pharmacy's SIGRE® bin. If in doubt, ask your pharmacist how to dispose of medicines and packaging that you no longer need. These measures will help to protect the environment.
6. Contents of the pack and other information
Composition of Omeprazole Pensavital
The active substance is omeprazole. Omeprazole Pensavital capsules contain 20 mg of omeprazole.
The other ingredients are hydroxypropyl methylcellulose, disodium phosphate dihydrate, talc, titanium dioxide (E 171), copolymer, methacrylic acid, triethyl citrate and sugar spheres (containing maize starch and sucrose). Capsule: titanium dioxide (E 171), water, gelatine, printing ink (containing Shellac, Ethyl alcohol, Isopropyl alcohol, Propylene glycol, N-butyl alcohol, Ammonium hydroxide, Potassium hydroxide, Purified water, Black iron oxide E-172). See section 2. Omeprazole Pensavital contains sucrose.
Product appearance and contents of the pack
Omeprazole Pensavital 20 mg capsules are made up of a white body, imprinted with ‘20’, and a white cap, imprinted with ‘OM’, containing spherical granules.
Pack sizes:
HDPE bottles containing 14 capsules. Blister pack of 14 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Manufacturer:
Towa Pharmaceutical Europe, S.L.
C/ de Sant Martí 75-97
08107 Martorelles (Barcelona)
Spain
This package leaflet was last reviewed in: February 2023
Detailed and up to date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/