Controloc Control - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient CONTROLOC 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 CONTROLOC Control tablets for more than 4 weeks without consulting a doctor.

What is in this leaflet

• 1. What CONTROLOC Control is and what it is used for

• 2. What you need to know before you take CONTROLOC Control

• 3. How to take CONTROLOC Control

• 4. Possible side effects

• 5. How to store CONTROLOC Control

• 6. Contents of the pack and other information

1. What CONTROLOC Control is and what it is used for

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

CONTROLOC 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 CONTROLOC 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 CONTROLOC Control

Do not take CONTROLOC 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 HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of HIV-infection) See ‘Other medicines and CONTROLOC Control’.

Warnings and precautions

Talk to your doctor or pharmacist before taking CONTROLOC 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.

• – if you have ever had a skin reaction after treatment with a medicine similar to CONTROLOC

Control that reduces stomach acid.

• – if you are due to have a specific blood test (Chromogranin A).

• – if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of

HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.

Do not take this product for longer than 4 weeks without consulting your doctor. If your reflux symptoms (heartburn or acid regurgitation) persist for longer than 2 weeks, consult your doctor who will decide about the need for long-term intake of this medicine.

If you take CONTROLOC Control for longer periods, this may cause additional risks, such as:

• – reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low body stores of Vitamin B12.

• – fracture of your hip, wrist or spine, especially if you already have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of getting osteoporosis (for example, if you are taking steroids).

• – falling magnesium levels in your blood (potential symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate). Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. You should talk to your doctor if you have been using this product for more than 4 weeks. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

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 associated with a small increase in infectious diarrhoea.

• – 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 CONTROLOC Control. Remember to also mention any other ill-effects like pain in your joints.

Your doctor may decide that you need some tests.

If you are due to have a blood test, tell your doctor that you are taking this medicine.

You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with CONTROLOC 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

CONTROLOC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.

Other medicines and CONTROLOC Control

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

• – HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection). You must not use CONTROLOC Control if you are taking HIV protease inhibitors. See ‘Do not take CONTROLOC 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 CONTROLOC Control treatment because pantoprazole can increase levels of methotrexate in the blood.

Do not take CONTROLOC 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 CONTROLOC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.

Pregnancy and, breast-feeding and fertility

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

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 CONTROLOC 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.

You should take this medicine for at least 2–3 consecutive days. Stop taking CONTROLOC 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 CONTROLOC 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 CONTROLOC 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 CONTROLOC 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 CONTROLOC 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 (frequency 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) :

you may notice one or more of the following – 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 particularly in areas of skin exposed to the sun. You may also have joint pain or flu-like symptoms, a fever, swollen glands (e.g. in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes.

• - 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:

• - Common side effects (may affect up to 1 in 10 people) benign polyps in the stomach.

• - 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; fracture in the hip, wrist or spine.

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

distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities; depression; increased bilirubin and fat levels in blood (seen in blood tests), breast 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).

• - Not known ( frequency cannot be estimated from the available data)

hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium, magnesium, calcium or potassium in blood (see section 2); rash, possibly with pain in the joints; feeling of tingling, prickling, pins and needles, burning sensation or numbness; inflammation in the large bowel, that causes persistent watery diarrhoea.

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 CONTROLOC 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 to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What CONTROLOC 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 (E421), crospovidone, povidone K90, calcium stearate.

Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium laurilsulfate, polysorbate 80, triethyl citrate.

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

What CONTROLOC 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.

CONTROLOC Control is available in Alu/Alu blisters 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-Straße 2, 78467 Konstanz

Germany

Manufacturer

Takeda GmbH

Production site Oranienburg

Lehnitzstraße 70–98, 16515 Oranienburg

Germany

For any information about this medicine, please

Authorisation Holder:

Belgie/Belgiqu­e/Belgien

Takeda Belgium

Tél/Tel: + 32 2 464 06 11

Efc^rapufl

Takega Etnrapua

Tea.: + 359 2 958 27 36

Česká republika

Takeda Pharmaceuticals Czech Republic s.r.o.

Tel: + 420 234722722

Danmark

Takeda Pharma A/S

Tlf: + 45 46 77 11 11

Deutschland

Takeda GmbH

Tel: +49 (0) 800 825 3324

Eesti

Takeda Pharma AS

Tel: +372 617 7669

EZZáSa

TAKEDA EAAAZ A.E

Tql: +30 210 6729570

España

Takeda Farmacéutica España S.A.

Tel: + 34 917 90 42 222

France Takeda France S.A.S. Tel: +33 1 40 67 33 00	Portugal Takeda – Farmacéuticos Portugal, Lda. Tel: + 351 21 120 1457
Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 96	Romania Takeda Pharmaceuticals SRL Tel: + 40 21 335 03 91
Ireland Takeda Products Ireland Limited Tel: + 353 16 42 00 21	Slovenija Takeda GmbH, Podružnica Slovenija Tel: + 386 (0) 59 082 480
Island Vistor hf. Simi: +354 535 7000	Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 600
Italia Takeda Italia S.p.A. Tel: +39 06 502601	Suomi/Finland Takeda Oy Puh/Tel: + 358 20 746 5000
Knnpog TAKEDA EAAAZ A.E Tql: +30 210 6729570	Sverige Takeda Pharma AB Tel: + 46 8 731 28 00
Latvija Takeda Latvia SIA Tel: + 371 67840082	United Kingdom Takeda UK Limited Tel: +44 (0)1628 537 900

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 changes may also help to relieve heartburn 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

• – Elevate bedhead (if you suffer from nocturnal symptoms)

• – Reduce intake of food that can cause heartburn. These might include: Chocolate, peppermint,