Pantecta Control - patient leaflet, side effects, dosage

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Takeda GmbH

Production site Oranienburg

Lehnitzstraße 70–98

D-16515 Oranienburg

Germany

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OF THE MARKETING AUTHORISATION

Medicinal product not subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

EXP

• 9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

• 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Takeda GmbH

Medicinal product not subject to medical prescription.

15. INSTRUCTIONS ON USE

For short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.

Take one tablet (20 mg) per day. Do not exceed this dose. This medicine may not bring immediate

CARDBOARD REINFORCEMENT

• 1. NAME OF THE MEDICINAL PRODUCT

PANTECTA Control 20 mg gastro-resistant tablets

Pantoprazole

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate).

• 4. PHARMACEUTICAL FORM AND CONTENTS 7 gastro-resistant tablets

14 gastro-resistant tablets

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Tablets should be swallowed whole.

Read the package leaflet before use.

6. SPECIAL WARNING TH	IT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH C	>F CHILDREN

f children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8.

E

RY DATE

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

PANTECTA Control 20 mg gastro-resistant tablets

Pantoprazole

Package leaflet: Information for the patient PANTECTA Control 20 mg gastro-resistant tablets

Pantoprazole

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 talk to a doctor if you do not feel better or if you feel worse after 2 weeks.

• – You should not take PANTECTA Control tablets for more than 4 weeks without consulting a

doctor.

What is in this leaflet

What PANTECTA Control is and what it is used for

What you need to know before you take PANTECTA Control

How to take PANTECTA Control

Possible side effects

How to store PANTECTA Control

Contents of the pack and other information

What PANTECTA Control is and what it is used for

PANTECTA Control contains the active substance pantoprazole, which blocks the ‘pump’ that produces stomach acid. Hence it reduces the amount of acid in your stomach.

PANTECTA Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.

Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”), which may become inflamed and painful. This may cause you symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with PANTECTA Control, but this medicine is not meant to bring immediate relief. It may be necessary to take the tablets for 2–3 consecutive days to relieve the symptoms.

You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.

2. What you need to know before you take PANTECTA Control

Do not take PANTECTA Control:

• – if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in

section 6).

• – if you are taking a medicine containing atazanavir (for the treatment of HIV-infection) See

‘Other medicines and PANTECTA Control’.

Warnings and precautions

Talk to your doctor before taking PANTECTA Control

if you have been treated for heartburn or indigestion continuously for 4 or more weeks

if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis

if you are over 55 years old with any new or recently changed reflux symptoms

if you have previously had a gastric ulcer or stomach surgery

if you have liver problems or jaundice (yellowing of skin or eyes)

if you regularly see your doctor for serious complaints or conditions

if you are due to have an endoscopy or a breath test called a C-urea test.

Tell your doctor immediately , before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease:

• – an unintentional loss of weight (not related to a diet or an exercise programme)

  
  

• – vomiting, particularly if repeated

• – vomiting blood; this may appear as dark coffee grounds in your vomit

• – you notice blood in your stools; which may be black or tarry in appearance

• – difficulty in swallowing or pain when swallowing

• – you look pale and feel weak (anaemia)

• – chest pain

• – stomach pain

• – severe and/or persistent diarrhoea, because this medicine has been associat

  ith a small

  
  

increase in infectious diarrhoea.

Your doctor may decide that you need some tests.

If you are due to have a blood test, tell your doctor that you are

You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with PANTECTA Control, but this medicine is not meant to bring immediate relief.

You should not take it as a preventive measure.

If you have been suffering from repetitive heartburn or indigestion symptoms for some time, remember to see your doctor regularly.

Children and adolescents

PANTECTA Control should not be lack of safety information in this

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines PANTECTA Control may stop certain other medicines from working properly. Especially medicines containing one of the following active substances:

• – atazanavir (used to treat HIV-infection). You must not use PANTECTA Control if you are taking atazanavir. See ‘Do not take PANTECTA Control’.

• – ketoconazole (used for fungal infections).

• – warfarin and phenprocoumon (used to thin blood and prevent clots). You may need further

blood tests

• – methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking

methotrexate your doctor may temporarily stop your PANTECTA Control treatment because pantoprazole can increase levels of methotrexate in the blood.

Do not take PANTECTA Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).

However, you may take PANTECTA Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant or while-breastfeeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you experience side effects like dizziness or disturbed vision, you should not drive or use machines.

3. How to take PANTECTA Control

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet a day. Do not exceed this recommended dose of 20 mg pantoprazole daily. rv

You should take this medicine for at least 2–3 consecutive days. Stop taking PANTECTA Control when you are completely symptom-free. You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with PANTECTA Control, but this medicine is not meant to bring immediate relief.

If you have no symptom-relief after taking this medicine for 2 weeks continuously, consult your doctor.

Do not take PANTECTA Control tablets for more than 4 weeks without consulting your doctor.

Take the tablet before a meal, at the same time every day. You should swallow the tablet whole with some water. Do not chew or break the tablet.

If you take more PANTECTA Control than you should

Tell your doctor or pharmacist if you have taken more than the recommended dose. If possible take your medicine and this leaflet with you

If you forget to take PANTECTA Control

Do not take a double dose to make up for the forgotten dose. Take your next, normal dose, the next day, at your usual time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately or contact the casualty department at your nearest hospital, if you get any of the following serious side effects. Stop taking this medicine straight away, but take this leaflet and/or the tablets with you.

• - Serious allergic reactions (rare: may affect up to 1 in 1,000 people) : Hypersensitivity

reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating.

• - Serious skin reactions (frequency not known: frequency cannot be estimated from the

available data) : rash with swelling, blistering or peeling of the skin, losing skin and bleeding around eyes, nose, mouth or genitals and rapid deterioration of your general health, or rash when exposed to the sun.

• - Other serious reactions (frequency not known) : yellowing of the skin and eyes (due to

severe liver damage), or kidney problems such as painful urination and lower back pain with fever.

Other side effects include:

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

headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind);

constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test.

Rare side effects :

distortion or complete lack of the sense of taste; disturbances in vision such as b pain in the joints; muscle pains; weight changes; raised body temperature; sw

extremities; depression; increased bilirubin and fat levels in blood (seen i

enlargement in males; high fever and a sharp drop in circulating granular white blood cells (seen in blood tests).

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

disorientation; reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets (seen in blood tests).

• - Frequency not known :

hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood.

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 By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store PANTECTA Control

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 carton and the blister after ‘EXP’. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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

6. Contents of the pack and other information

What PANTECTA Control contains

• – The active substance is pantoprazole. Each tablet contains 20 mg pantoprazole (as sodium

sesquihydrate).

• – The other ingredients are:

• – Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium

stearate.

• – Coating: hypromellose, povidone, titanium dioxide (Ei7i), yellow iron oxide (E172),

propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate.

• – Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution,

concentrated.

What PANTECTA Control looks like and contents of the pack

The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.

PANTECTA Control is available in Alu listers with or without cardboard reinforcement.

Packs containing 7 or 14 gastro-resistant tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Takeda GmbH

Byk-Gulden-StraBe 2, 78467 Konstanz

Germany

Manufacturer

Takeda GmbH Productio Lehnitz Ge

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien

Takeda Belgium

Tél/Tel: + 32 2 464 06 11

Suomi/Finland

Takeda Oy

Puh/Tel: + 358 20 746 5000

Sverige

Takeda Pharma AB

Tel: + 46 8 731 28 00

Latvija

Takeda Latvia SIA

Tel: + 371 67840082

This leaflet was last revised in {MM/YYYY }

Detailed information on this medicine is available on the European Medicines Agency web site:

The following recommendations for lifestyle and dietary change or acid related symptoms.

• – Avoid large meals

• – Eat slowly

• – Stop smoking

• – Reduce alcohol and caffeine consumption

• – Reduce weight (if overweight)

• – Avoid tight-fitting clothing or belts

• – Avoid eating less than three hours before bedtime