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

• Lansoprazol Pensa gastro-resistant capsule, hard PL
• Lansoprazol Pensa gastro-resistant capsule, hard OTC PL
• Lansoprazol Pensa gastro-resistant capsule, hard ENG PL

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The PL includes alternative texts for different legal status in different countries as follows:

-Boxed texts are only applicable for OTC versions.

-[Grey-shaded texts in brackets] are only applicable for prescription versions.

For OTC use in Sweden, please refer to the approved Swedish package leaflet published on the MPA website.

Package leaflet: Information for the user

Lansoprazol Pensa 15 mg gastro-resistant capsules, hard

Lansoprazol Pensa 30 mg gastro-resistant capsules, hard

Lansoprazole

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.

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

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

• Ask your pharmacist if you need more information or advice.

• 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.

• You must contact a doctor if your symptoms worsen or do not improve after 14 days.

What is in this leaflet

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

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

3. How to take Lansoprazol Pensa

4. Possible side effects

6. Contents of the pack and other information

The active ingredient in Lansoprazole Pensa is lansoprazole, a proton pump inhibitor.

Lansoprazole works by lowering the amount of acid in your stomach

Lansoprazol Pensa is indicated for use in:

The physician can prescribe Lansoprazol Pensa for the following indications:

- treatment of ulcers in your stomach or duodenum

- treatment of inflammation of the oesophagus (gastro-oesophageal reflux disease)

- prevention of gastro-oesophagealreflux disease

- treatment of heartburn and acid refluxes

- treatment and prevention of ulcers in patients that needs continuous treatment with NSAIDs ( NSAIDs are used for treatment of pain and inflammation)

- treatment of Zollinger-Ellison’s syndrome.

Do not take Lansoprazol Pensa

- if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6)..

- if you are taking a medicine containing atazanavir (used for treatment of HIV).

Warnings and precautions

Talk to your doctor before taking Lansoprazol Pensa:

• If you have a serious liver disease, ask your doctor for advice before taking Lansoprazol Pensa.

• If you have a serious liver disease. He/she might need to adjust the dose

• If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol Pensa

that reduces stomach acid.

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 Lansoprazol Pensa. Remember to also mention any other ill-effects like pain in your joints.

The doctor can perform or may have perfomed an examination called endoscopy to diagnose your disease and/or to exclude malignant disease.

If diarrhea occurs during the treatment of Lansoprazol Pensa, contact your doctor immediately. Lansoprazol Pensa has been associated with an increased occurrence of contagious diarrhea.

If your doctor has prescribed Lansoprazol Pensa together with anti-inflammatory medicines for treatment of pain or rheumatic disease: read the package leaflets of these medicines carefully.

Taking a proton pump inhibitor like Lansoprazol 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 lansoprazole on a long-term basis (longer than 1 year) your doctor will probably check you regularly. Tell your doctor if you notice any new or unusual symptoms or other details when you see him/her.

Other medicines and Lansoprazol Pensa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

In particular, check with your doctor or pharmacist if you are taking any of the following medicines. This is because lansoprazole can affect the way some other medicines work:

- Ketoconazole, itraconazole, rifampicin (used to treat infections)

- Digoxin(used to treat heart problems)

- Theophylline (used to treat asthma)

- Tacrolimus (used to prevent transplant rejection)

- Fluvoxamine (used to treat depression and other psychiatric problems)

- Antacids (used to treat heartburn or acid reflux)

- Sucralfate (used for healing ulcers)

- St John’s wort (Hypericum perforatum) (used to treat mild depression)

Lansoprazol Pensawith food and drink

For best effect of the medicine, you should take Lansoprazol Pensa at least 30 minutes before food.

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.

Driving and using machines

Adverse drug reactions such as dizziness, vertigo, tiredness and visual disturbances may occur in patients taking Lansoprazol Pensa. These adverse reactions may decrease the ability to drive or use machines.

Lansoprazol Pensa contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Swallow your capsule whole with a glass of water. If you think that it is difficult to swallow the capsules your doctor can advice you of other ways of taking this medicine. Do not crush or chew the capsules or the content of an emptied capsule, because this will prevent the medicine from working as it should.

If you are taking Lansoprazol Pensa once a day, take it at the same time every day. You will get the best results if you take the medicine in the morning.

If you are taking Lansoprazol Pensa twice a day, take the first dose in the morning and the second dose in the evening

[To be included nationally if applicable]

Relief of occasional symptoms of heartburn and acid reflux: The usual dose is 15-30 mg (i.e. 1-2 capsules à 15 mg or 1 capsules à 30 mg) when needed. Do not take more than 30 mg per day. If the symptoms have not resolved within 14 days, contact your doctor, since your symptoms can be related to something else. It is very important that you contact your doctor if you have frequent recurring symptoms.

If your doctor has prescribed Lansoprazol Pensa for another indication or in another dose, always take Lansoprazol Pensaexactly as your doctor has told you. You should check with your doctor if you are not sure.

The dose of Lansoprazol Pensa prescribed depends on your condition. The usual doses for adults are stated below. Your doctor sometimes prescribes a different dose, and will tell you how long your treatment should continue.

Treatment of heartburn and acid refluxes

One 15 mg or 30 mg capsule every day for 4 weeks. If the symptoms persist, contact your doctor. If the symptoms have not been relieved within 4 weeks, contact your doctor.

Treatment of ulcers of the duodenum

One 30 mg capsule every day for 2 weeks.

Stomach ulcers:

One 30mg capsule every day for 4 weeks.

Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg capsule every day for 4 weeks.

Preventative long-term treatment of gastro-oesophagealreflux disease

One 15 mg capsule every day, the doctor can adjust the dose to one 30 mg capsule every day.

Treatment of ulcers of the duodenum or stomach in patients that needs continuing NSAID-treatment

One 30mg capsule every day for 4 weeks.

Prevention of ulcers of the duodenum or stomach in patients that needs continuing NSAID-treatment

One 15 mg capsule every day, the doctor can adjust the dose to one 30 mg capsule every day.

Zollinger-Ellison syndrome:

The usual dose is two 30mg capsules every day to start with. Your doctor will then decide the dose which is best for you depending on how you respond to the treatment.

Use in children

Lansoprazol Pensa should not be given to children.

Lansoprazol Pensa should not be use by children or adolescents under the age of 18 without a prescription by a doctor.

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

If you take more Lansoprazol Pensa than you should

< To be completed nationally>

If you have taken more of this medicine than directed, or if a child accidentally has taken this medicine, please contact your doctor or emergency unit for judgement of the risk and advice.

If you forget to take Lansoprazol Pensa

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. If this occurs, skip the missed dose and take the capsules as usual. Do not take a double dose to make up for a forgotten capsule.

If you stop takingLansoprazol Pensa

Do not stop taking the medicine even if your symptoms have improved. You might not be fully recovered and the symptoms might come back if you do not finish the treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lansoprazol Pensa can cause side effects, although not everybody gets them.

The following side effects are common (affects more than 1 of 100 patients):

- headache, feeling dizzy

- diarrhea, constipation, stomach pains, feeling sick (nausea) or being sick (vomiting), wind, dry or sore mouth or throat

- skin rash, itching

- changes in the way your liver is working (shown by a blood test)

- feeling tired

The following side effects are uncommon (affects less than 1 of 100 patients):

- depression

- joint or muscle pain

- water retention which may cause swollen arms or legs

- change in the number of blood cells

- fracture of the hip, wrist or spine (if Lansoprazol Pensa is used in high doses during a long time period)

The following side effects are rare (affects less than 1 of 1000 patients):

• fever

• feeling restless, drowsy or confused, hallucinations, sleeping difficulties, problems with your vision, vertigo

- a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis)

- skin reactions such as burning or pricking feeling under the skin, bruising, rash and excessive sweating

- being more sensitive to the sun and light

- hair loss

- creeping on the skin (paraesthesia), trembling

- anemia (pale skin)

- kidney problems

- inflammation of the pancreas

- inflammation of the liver (symptoms are yellowing of the skin or eyes)

- swelling of the breasts in men, impotence

- candidiasis (fungal infection, may affect skin or mucous membranes)

- angiooedema. See a doctor immediately if you show signs of angiooedema, such as swollen face, tongue or throat, difficulties when swallowing, nettle rash and breathing difficulties.

The following side effects are very rare (affects less than 1 of 10000 patients):

- serious hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction can be fever, rash, swelling and sometimes a lowering of the blood pressure

- inflammation of your mouth (stomatitis)

- colitis (bowel inflammation)

- changes in test values such as sodium, cholesterol and triglyceride levels

- very serious skin reactions with rash, blistering, serious inflammation and peeling of the skin

- in very rare cases Lansoprazol Pensa can cause a reduction of the number of white blood cells so that the immune system is impaired. If you get an infection with symptoms such as fever with severely impaired general condition or fever with local signs of infections such as pain in the throat/pharynx/mouth or difficulties in passing water (urine), see a doctor immediately. Your doctor will order a blood sample to check if your number of white blood cells has been reduced (agranulocytosis).

Frequency not known

• If you are on Lansoprazol Pensa 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.

• Rash, possibly with pain in the joints

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.

5. How to store Lansoprazol Pensa

Keep this medicine out of the sight and reach of children.

Blister: Store below 25 C.

Plastic jar: Store below 30 C. Keep the plastic jar tightly closed, in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the blister/label and carton. The expiry date refers to the last day of that month.

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.

6. Contents of the pack and other information

What Lansoprazol Pensa contains

- The active substance is lansoprazole.

- The other ingredients are: Capsule: hypromellose (E 464), talc, titanium dioxide (E 171),

methacrylic acid – ethyl acrylate copolymer (1:1), triethyl citrate, sugar spheres (sucrose and corn starch).

Capsule shell:titanium dioxide (E 171), gelatine, purified water. Printing ink: shellac and black iron oxide (E172).

What Lansoprazol Pensa looks like and contents of the pack

Description:

Lansoprazol Pensa 15 mg: Opaque white, hard capsules.

Each capsule is marked with “LAN 15”. Contains white to beige granules with gastro-resistant coating.

Lansoprazol Pensa 30 mg: Opaque white, hard capsules.

Each capsule is marked with “LAN 30”. Contains white to beige granules with gastro-resistant coating.

Pack-sizes:

<To be completed nationally>

15 mg:

7, 14 and 28 gastro-resistant capsules in a plastic jar

30 mg:

7 and 14 gastro-resistant capsules in a plastic jar

15 mg:

7, 14, 28, 42 and 56 gastro-resistant capsules in blisters

56 (2x28) and 100 (2x50) gastro-resistant capsules in a plastic jar

30 mg:

7, 14, 28, 42 and 56 gastro-resistant capsules in blisters

28, 56 (2x28) and 100 (2x50) gastro-resistant capsules in a plastic jar

Not all pack sizes may be marketed.

Marketing Authorisation Holder

<To be completed nationally>

Pensa Pharma AB

Birger Jarlsgatan 22

114 34 Stockholm

Sweden

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

Country	Name of product:
SE, DK, DE, NO	Lansoprazol Pensa

This leaflet was last revised in 2016-02-25