Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - raloxifene

Document Subject

Generated Narrative: MedicinalProductDefinition mpe27db7be57c176c4d945aa1d06a95aa5

identifier: http://ema.europa.eu/identifier/EU/1/10/627/001-003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Raloxifene Teva 60 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-e27db7be57c176c4d945aa1d06a95aa5

identifier: http://ema.europa.eu/identifier/EU/1/10/627/001-003

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - raloxifene

Attesters

What is in this leaflet:

1. What Raloxifene Teva is and what it is used for
2. What you need to know before you take Raloxifene Teva
3. How to take Raloxifene Teva
4. Possible side effects
5. How to store Raloxifene Teva
6. Contents of the pack and other information

Raloxifene Teva is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Teva reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown.

How Raloxifene Teva works

Raloxifene Teva belongs to a group of non-hormonal medicines called selective oestrogen receptor modulators (SERMs). When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down. Raloxifene Teva mimics some of the helpful effects of oestrogen after the menopause.

Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause. Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.

Do not take Raloxifene Teva

• If you are allergic to raloxifene or any of the other ingredients of this medicine (listed in section 6).
• If there is still a possibility that you can get pregnant, Raloxifene Teva could harm your unborn child.
• If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
• If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment or cholestatic jaundice).
• If you have any unexplained vaginal bleeding. This must be investigated by your doctor.
• If you have active uterine cancer, as there is insufficient experience of Raloxifene Teva use in women with this disease.
• If you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Raloxifene Teva:

• If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness.
• If you are receiving oral oestrogen therapy.
• If you are suffering from breast cancer, as there is insufficient experience of Raloxifene Teva use in women with this disease.
• If you have had a cerebrovascular accident (e.g. stroke), or if your doctor has told you that you are at high risk of having one.
• If you have liver problems, as there is insufficient experience in people with liver problems. If you do have liver problems and your doctor still recommends treatment, then you may need some blood tests during treatment.

It is unlikely that Raloxifene Teva will cause vaginal bleeding. So any vaginal bleeding while you take Raloxifene Teva is unexpected. You should have this investigated by your doctor.

Raloxifene Teva does not treat postmenopausal symptoms, such as hot flushes.

Raloxifene Teva lowers total cholesterol and LDL ("bad") cholesterol. In general, it does not change triglycerides or HDL ("good") cholesterol. However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking Raloxifene Teva.

Other medicines and Raloxifene Teva

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

If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.

Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine.

Pregnancy and breast-feeding Raloxifene Teva is for use only by postmenopausal women and must not be taken by women who could still have a baby. Raloxifene Teva could harm your unborn child.

Do not take Raloxifene Teva if you are breast-feeding as it might be excreted in mother's milk.

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 medicines.

Driving and using machines Raloxifene Teva has no or negligible effects on driving or using machines.

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

The recommended dose is one tablet a day. It does not matter at what time of the day you take your tablet but taking the tablet at the same time each day will help you remember to take it. You may take it with or without food.

The tablets are for oral use. Swallow the tablet whole. If you wish you may take a glass of water with it.

Your doctor will tell you how long you should continue to take Raloxifene Teva. The doctor may also advise you to take calcium and vitamin D supplements.

If you take more Raloxifene Teva than you should Tell your doctor or pharmacist. If you take more Raloxifene Teva than you should you could have leg cramps and dizziness.

If you forget to take Raloxifene Teva Take a tablet as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Raloxifene Teva You should talk to your doctor first. It is important that you continue taking Raloxifene Teva for as long as your doctor prescribes the medicine. Raloxifene Teva can treat or prevent your osteoporosis only if you continue to take the tablets.

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. The majority of side effects seen with Raloxifene Teva have been mild.

Very common (may affect more than 1 in 10 people)

• Hot flushes (vasodilatation).
• Flu syndrome.
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
• Increased blood pressure

Common (may affect up to 1 in 10 people)

• Headache including migraine
• Leg cramps.
• Swelling of hands, feet and legs (peripheral oedema).
• Gallstones.
• Rash
• Mild breast symptoms such as pain, enlargement and tenderness

Uncommon (may affect up to 1 in 100 people)

• Increased risk of blood clots in the legs (deep vein thrombosis).
• Increased risk of blood clots in the lungs (pulmonary embolism).
• Increased risk of blood clots in the eyes (retinal vein thrombosis).
• Skin around the vein is red and painful (superficial vein thrombophlebitis).
• Blood clot in an artery (for example stroke, including an increased risk of dying from stroke)
• Decrease in the number of the platelets in the blood

In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene Teva. 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.

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 outer carton or foil after EXP. The expiry date refers to the last day of that month.

Do not store above 25 C. Store in the original package 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 to protect the environment.

What Raloxifene Teva contains

• The active substance is raloxifene hydrochloride. Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene.
• The other ingredients are: Tablet core: pregelatinized starch (maize), magnesium stearate, povidone (K30), colloidal anhydrous silica and microcrystalline cellulose, silicified.
  Tablet coating: polydextrose (E1200), titanium dioxide (E171), hypromellose (E464) and macrogol 4000. What Raloxifene Teva looks like and contents of the pack

The film-coated tablets are white to off-white, oval shaped and embossed with the number 60 on one side and N on the other side.

Raloxifene Teva 60 mg is available in pack sizes of 14, 28 and 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Teva B.V. Swensweg 5 2031GA Haarlem The Netherlands

Manufacturers: Teva Pharmaceutical Works Private Limited Company Pallagi t Debrecen H-4Hungary

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Merckle GmbH
Ludwig-Merckle-Stra e 3 89143 Blaubeuren Germany

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

Belgi /Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

: +359 24899Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007Magyarorsz g
Teva Gy gyszergy r Zrt.
Tel: +36 12886Danmark
Teva Denmark A/S
Tlf: +45 44985Malta
Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland TEVA GmbH Tel: +49 73140Nederland
Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
Specifar A.B.E.E. : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
Specifar A.B.E.E.

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in MM/YYYY

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