Takeda Pharma

Tablet 15 mg
(Not provided)(White to off-white, round, cupped, 7.0 x 7.0 mm, and marked 15 on one side and ACTOS on the other side.)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Actos is and what it is used for 
2. What you need to know before you take Actos 
3. How to take Actos 
4. Possible side effects 
5. How to store Actos 
6. Contents of the pack and other ingredients information 

1. What Actos is and what it is used for

Actos contains pioglitazone. It is a treatment for diabetes that is used to treat type 2 diabetes mellitus in adults, when metformin is not suitable or sufficient, therapy. This type of diabetes is also called “non-insulin-dependent” and usually occurs in adulthood.

Actos helps keep blood sugar levels under control in type 2 diabetes so that the body can make better use of the insulin that is produced. 3 to 6 months after starting treatment, your doctor will check if Actos is working for you.

Actos can be used as the only treatment in patients who cannot take metformin and when treatment with diet and exercise fails to keep blood sugar levels under control. Actos can also be added to other treatments (such as metformin, sulphonylureas, or insulin ) that have failed to adequately control blood sugar levels.

2. What you need to know before you take Actos

Do not take Actos

  • if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
  • if you have or have had heart failure in the past.
  • if you have liver disease.
  • if you have had diabetic ketoacidosis (a complication of diabetes that causes rapid weight loss, nausea, and vomiting).
  • if you have or have ever had bladder cancer
  • if you have blood in your urine that your doctor has not examined further.

Warnings and cautions

Talk to your doctor or pharmacist before taking Actos (see also section 4).

  • if you are accumulating water ( fluid retention ) or have problems with heart failure, especially if you are over 75 years old. Tell your doctor if you are taking anti-inflammatory medications that may cause you to accumulate fluid and swell.
  • if you have a type of diabetes-related eye disease called macular edema (swelling of the back of the eye).
  • if you have ovarian cysts ( polycystic ovary syndrome ). There may be an increased chance of getting pregnant because you may ovulate again when you take Actos. If this affects you, use appropriate contraception to avoid unplanned pregnancy.
  • if you have liver or heart problems. Before you start using Actos, you will be given blood tests to check your liver function. This check may be repeated at intervals. Some patients who have had type 2 diabetes mellitus and heart disease for many years or previous strokes developed heart failure during treatment with Actos and insulin. Tell your doctor as soon as possible if you get signs of heart failure such as unexpected shortness of breath, rapid weight gain, or local swelling ( edema ).

If you are taking Actos with other diabetes medicines, it is likely that your blood sugar may drop below normal levels (hypoglycemia).

You may also experience a decrease in the number of blood cells ( anemia ).

Fracture

A higher incidence of bone fractures has been observed in patients, especially in women taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and young people

Use in children and adolescents under 18 years of age is not recommended.

Other medicines and Actos

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You can normally continue to use other medicines when you are being treated with Actos. However, some drugs are especially likely to affect the amount of sugar in your blood:

  • Gemfibrozil (cholesterol-lowering)
  • Rifampicin (used to treat tuberculosis and other infections )

Tell your doctor or pharmacist if you are taking any of these medicines. Your blood sugar will be monitored and your dose of Actos may need to be adjusted.

Actos with food and drink

The tablets can be taken with or without food. The tablets should be swallowed together with a glass of water.

Pregnancy and breastfeeding

Tell your doctor

  • you are pregnant or think you are pregnant or planning to become pregnant.
  • if you are breast-feeding or planning to breast-feed your baby.

Your doctor will advise you to stop taking this medicine.

Driving and using machines

This medicine does not affect your ability to drive or use machines, but use caution if you experience visual disturbances.

Actos contains lactose monohydrate

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

3. How to take Actos

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The usual starting dose is a 15 mg or 30 mg pioglitazone tablet once a day. Your doctor may increase the dose to a maximum of 45 mg once a day. Your doctor will tell you which dose to take. If you have the impression that the effect of Actos is too weak, talk to your doctor.

When Actos is taken in combination with other medicines used to treat diabetes(such as insulin, chloropropamide, glibenclamide, gliclazide, tolbutamide), your doctor will tell you if you need to take a smaller dose of any of your medicines.

Your doctor will take blood tests regularly during treatment with Actos. This is done to check that the liver is functioning normally.

If you are recommended a special diet for diabetes, you should continue with this while taking Actos.

Check your weight regularly and tell your doctor if the weight increases.

If you take more Actos than you should

If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. Your blood sugar can fall below normal levels and can be increased by consuming sugar. It is recommended to carry sugar cubes, sweets, biscuits, or sugary fruit drinks.

If you forget to take Actos

Try to take Actos daily as prescribed. However, if you miss a dose, just continue with the next dose as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Actos

Actos should be used daily to achieve the desired effect. If you stop taking Actos, your blood sugar level may increase. Talk to your doctor before stopping this 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, this medicine can cause side effects, although not everybody gets them.

In particular, patients have experienced the following serious side effects:

Heart failure has been common (may affect up to 1 in 10 people) in patients taking Actos in combination with insulin. The symptoms are abnormal shortness of breath or rapid weight gain or local swelling ( edema ). Seek medical attention immediately if you experience any of these, especially if you are over 65 years old.

Bladder cancer has been detected in some patients (may affect up to 1 in 100 people) taking Actos. Signs and symptoms of this can be blood in the urine, pain when urinating, or urinary incontinence (sudden need to urinate). Contact your doctor as soon as possible if you experience any of these symptoms.

It has also been very common (may affect more than 1 in 10 people) that patients taking Actos in combination with insulin have experienced local swelling ( edema ). Contact your doctor as soon as possible if you experience this side effect.

It has been common (may affect up to 1 in 10 people) that female patients taking Actos have reported bone fractures. Bone fractures have also been reported in male patients taking Actos (occurs in an unknown number of users). Contact your doctor as soon as possible if you experience this side effect.

Blurred vision due to swelling (or fluid) in the back of the eye has also been reported in patients taking Actos (no known frequency, can not be calculated from the available data). Contact your doctor as soon as possible if you experience this symptom for the first time. Also, contact your doctor as soon as possible if you already have blurred vision and the symptom worsens.

Allergic reactions have been reported with no known frequency (cannot be calculated from the available data) in patients taking Actos. If you get severe allergic reactions such as hives or swelling of your face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately.

The other side effects that have occurred in patients taking Actos are:

common (may affect up to 1 in 10 people)

  • respiratory tract infection
  • visual impairment
  • weight gain
  • numbness

uncommon (may affect up to 1 in 100 people)

  • sinusitis
  • insomnia

has been reported (occurs in an unknown number of users)

  • elevated levels of liver enzymes
  • allergic reactions

The other side effects that have been reported in some patients who have used Actos with another diabetes medicine are:

very common (may affect more than 1 user in 10)

  • decreased blood sugar (hypoglycemia)

common (may affect up to 1 in 10 people)

  • headache
  • dizziness
  • joint pain
  • impotence
  • back pain
  • respiratory distress
  • a slight decrease in the number of red blood cells
  • weather voltage

uncommon (may affect up to 1 in 100 people)

  • sugar in the urine, egg whites in the urine
  • increase of the enzyme s
  • dizziness
  • sweating
  • fatigue
  • increased appetite.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Actos

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 blister after EXP. The expiration date is the last day of the specified month.

No special storage instructions are required for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance in Actos is pioglitazone.
  • Each Actos 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
  • Each Actos 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
  • Each Actos 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
  • The other ingredients are lactose monohydrate, hypromellose, carmellose calcium, and magnesium stearate. See section 2 “Actos contains lactose monohydrate”.

What the medicine looks like and the contents of the pack

  • Actos 15 mg tablets are white to off-white, round, cupped (convex) tablets marked “15” on one side and “ACTOS” on the other side.
  • Actos 30 mg tablets are white to off-white, round, flat tablets marked “30” on one side and “ACTOS” on the other side.
  • Actos 45 mg tablets are white to off-white, round, flat tablets marked “45” on one side and “ACTOS” on the other side.

The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Takeda Pharma A / S, Dybendal Alle 10, DK-2630 Taastrup, Denmark.

Manufacturer

Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland.

Lilly SA, Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spain.

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienTakeda BelgiumTel: +32 2 464 06 11takeda-belgium@takeda.com LithuaniaEli Lilly Holdings Limited sharesTel. +370 (5) 2649600
BulgariaTakade BulgariaTel .: + 359 2 958 27 36; + 359 2 958 15 29 Luxembourg / LuxemburgTakeda BelgiumTel: +32 2 464 06 11takeda-belgium@takeda.com
Czech RepublicELI LILLY ČR, sroTel: + 420 234 664 111 HungaryLilly Hungary Kft.Tel: + 36 1 328 5100
DenmarkTakeda Pharma A / STel: +45 46 77 11 11 MaltaTakeda Italia SpATel: +39 06 502601
GermanyTakeda GmbHTel: 0800 825 3325medinfo@takeda.de The NetherlandsEli Lilly Netherlands BVTel: + 31 (0) 30 60 25 800
EestiTakeda Pharma ASTel: +372 617 7669
NorwayTakeda ASTel: +47 6676 3030infonorge@takeda.com
GreeceΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.:Ηλ: +30 210 629 4600 AustriaTakeda Pharma Ges.mbHTel: +43 (0) 800 20 80 50
SpainLilly SATel: + 34 (91) 663 50 00 PolandTakeda Polska Sp. z ooTel .: +48 22 608 13 00
FranceTakeda FranceTel: +33 1 46 25 16 16 PortugalLilly Portugal – Pharmaceutical Products, LdaTel: + 351 21 412 6600
CroatiaTakeda Pharmaceuticals Croatia doo 
Tel: +385 1 377 88 96
RomaniaEli Lilly România SRLTel: +40 21 4023000
IrelandTakeda Products Ireland LimitedTel: +353 (0) 1 6420021 SloveniaTakeda Pharmaceuticals Slovakia sroTel: +421 (2) 20 602 600
IcelandVistor hf.Phone: +354 535 7000vistor@vistor.is Slovak RepublicEli Lilly Slovakia, sroTel: + 421 220 663 111
ItalyTakeda Italia SpATel: +39 06 502601 Finland / FinlandOy Eli Lilly Finland AbPuh / Tel: + 358 (0) 9 8545250
ΚύπροςTakeda Pharma A / S:Ηλ: +45 46 77 11 11
LatviaEli Lilly Holdings Limited is a Latvian companyTel: + 371 6 7 364 000 United KingdomTakeda UK LtdTel: +44 (0) 1628 537 900

Muhammad Nadeem

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