Pantecta Control
pantoprazole
Medicinal product no longer authorised
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 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
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.
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’.
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
Medicinal product no longer authorised
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.
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.
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 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.
PANTECTA 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..
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.
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.
Medicinal product no longer authorised
If you experience side effects like dizziness or disturbed vision, you should not drive or use machines.
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 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.
Tell your doctor or pharmacist if you have taken more than the recommended dose. If possible take your medicine and this leaflet with you
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
around eyes, nose, mouth or genitals and rapid deterioration of your general health, or rash when exposed to the sun.
Medicinal product no longer authorised
Other side effects include:
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.
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).
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).
hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood.
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.
Medicinal product no longer authorised
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.
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 (E171), 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.
The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
PANTECTA 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.
Takeda GmbH
Byk-Gulden-Straße 2, 78467 Konstanz Germany
Takeda GmbH
Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Takeda Belgium
Tél/Tel: + 32 2 464 06 11
Takeda, UAB
Tel: +370 521 09070
Такеда България
Teл.: + 359 (2) 958 27 36
Takeda Belgium
Tél/Tel: + 32 2 464 06 11
Takeda Pharmaceuticals Czech Republic s.r.o. Tel: + 420 234 722 722
Medicinal product no longer authorised
Takeda Pharma A/S Tlf: + 45 46 77 11 11
Takeda Italia S.p.A. Tel: +39 06 502601
Takeda GmbH
Tel: 0800 825 3324
Takeda Nederland bv Tel: +31 23 56 68 777
Takeda Pharma AS Tel: +372 617 7669
Takeda Nycomed AS Tlf: + 47 6676 3030
TAKEDA ΕΛΛΑΣ Α.Ε Τηλ: +30 210 6729570
Takeda Pharma Ges.m.b.H. Tel: +43 (0)800-20 80 50
Takeda Farmacéutica España S.A. Tel: + 349 1 714 9900
Takeda Polska Sp. z o.o. Tel.: + 48 22 608 13 00
Takeda France S.A.S. Tél: + 33 1 46 25 16 16
Takeda - Farmacêuticos Portugal, Lda. Tel: + 351 21 120 1457
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
Takeda Pharmaceuticals SRL Tel: + 40 21 335 03 91
Takeda Products Ireland Limited Tel: + 353 16 42 00 21
Takeda GmbH, Podružnica Slovenija
Tel: + 386 (0) 59082480
Vistor hf.
tel: +354 535 7000
Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20602600
Takeda Italia S.p.A. Tel: +39 06 502601
Takeda Oy
Puh/Tel: + 358 20 746 5000
TAKEDA ΕΛΛΑΣ Α.Ε Τηλ: +30 210 6729570
Medicinal product no longer authorised
Takeda Pharma AB Tel: + 46 8 731 28 00
Takeda Latvia SIA Tel: + 371 67840082
Takeda UK Limited
Tel: +44 (0)1628 537 900
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, spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.