Patient leaflet - UTROGESTAN VAGINAL 200 MG CAPSULES
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PACKAGE LEAFLET: INFORMATION FOR THE USER UTROGESTAN VAGINAL ® 200mg Capsules progesterone
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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* Keep this leaflet. You may need to read it again.
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* If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- 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.
WFaHslnthlsTeafletF "
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1. What Utrogestan Vaginal is and what it is used for
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2. What you need to know before you use Utrogestan Vaginal
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3. How to use Utrogestan Vaginal
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4. Possible side effects
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5. How to store Utrogestan Vaginal
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6. Contents of the pack and other information
1. What Utrogestan Vaginal is and what it is used for
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The name of your medicine is Utrogestan Vaginal 200mg Capsules (called Utrogestan Vaginal in this leaflet).
Utrogestan Vaginal contains a hormone called progesterone.
What Utrogestan Vaginal is used for
Utrogestan Vaginal can be used to support pregnancy during in vitro fertilization (IVF) cycles, or to prevent a preterm singleton birth in certain women.
To support pregnancy
Utrogestan Vaginal is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program.
recently taken or might take any other medicines. This “includes ■meditines’obtainedwithout’a prescriptron, “
including herbal medicines. This is because Utrogestan Vaginal can affect the way some other medicines work. Also some other medicines can affect the way Utrogestan Vaginal works.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
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* Bromocriptine used for problems with the pituitary gland or Parkinson's Disease.
- Ciclosporin (used to suppress the immune system).
- Rifamycin medicines such as rifampicin (used to treat – “infectionsJ7 —
- Ketoconazole (used for fungal infections).
Utrogestan Vaginal with food and drink
Utrogestan Vaginal is to be administered intravaginally. Food and drink have no effect on the treatment.
Pregnancy breast-feeding and fertility
- Utrogestan Vaginal will support pregnancy if you are having fertility treatment See Section 3 on how to use Utrogestan Vaginal.
- Do not use Utrogestan Vaginal if you are breastfeeding.
Driving and using machines
Utrogestan Vaginal has negligible effects on driving or using machinery.
Utrogestan Vaginal contains soybean lecithin
If you are allergic to peanut or soya, do not use this medicinal product.
3. How to use Utrogestan Vaginal
2. What you need to know before you use Utrogestan Vaginal
W00/o
Calidad y gramaje del papel:
Quality and weight of the paper:
60 gr/m2.
Colores: A NEGRO / BLACK
Colors: W 100 %
Codigo de Barras Barcode
| — | Codigo Laetus Laetus code |
Codigo Braille Braille code
Reservas para fecha y caducidad
Reserves to date and expiration time
Reservas para acabados (barnices,…)
Reserves for finished (varnishes,…)
Otras especificaciones tecnicas:
Another technical details:
Area libre de elementos g rations NO imprimible
Free graphic elements area NON-printable
Lineas de corte, de plegado o referencias tecnicas. NO imprimibles
Cutting or folding lines or technical references.
NON-printable
reverso / back
10 I mm "
pul
I mm I
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Not known (frequency cannot be estimated from the available data):
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– vaginal discharge
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– vaginal haemorrhage
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– itching
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 website or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine
5. How to store Utrogestan Vaginal
This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgaria: Utrogestan 200 mg vaginal capsules,
soft
Croatia: Utrogestan 200 mg meke kapsule za
rodnicu
Czech Republic: Progesteron Besins 200 mg mekke tobolky Estonia: Utrogestan 200 mg vaginaalpehmekapslid
Hungary: Utrogestan 200 mg lagy huvelykapszula
Ireland: Utrogestan Vaginal 200mg Vaginal
Capsules, soft
Latvia: Progesterone Besins 200 mg vaginalas
mikstas kapsulas
Lithuania: Progesterone Besins 200 mg maksties
minkstosios kapsules
Netherlands: Utrogestan 200 mg, zachte capsules
voor vaginaal gebruik
Norway: Utrogestan 200 mg vaginalkapsler, myke
Poland: Utrogestan 200 mg, kapsulki
dopochwowe, mi^kkie
Slovakia: Utrogestan 200 mg, makke vaginalne
kapsuly
Slovenia: Utrogestan 200 mg mehke vaginalne
kapsule
Sweden: Utrogestan 200 mg mjuk Vaginalkapsel
United Kingdom: Utrogestan Vaginal 200mg Capsules
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
- This medicine does not require any special storage conditions.
- 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.
6. contents of the pack and other information
What Utrogestan Vaginal contains
- The active substance is progesterone. Each capsule contains 200mg progesterone.
- The other ingredients are sunflower oil and soybean lecithin. The other ingredients in the capsule shell are gelatin, glycerol, titanium dioxide (E171) and water, purified.
What Utrogestan Vaginal looks like and contents of the pack
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* Utrogestan Vaginal are oval and slightly yellow soft capsules, containing whitish oily suspension.
- They are supplied in cartons containing PVC/Aluminium blisters of 15, 21,45 or 90 capsules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Utrogestan in the UK is held by Besins Healthcare, Avenue Louise 287,1050 Brussels, Belgium.
Utrogestan Vaginal is manufactured by:
Cyndea Pharma, S.L.
Poligono Industrial Emiliano Revilla Sanz,
Avenida de Agreda, 31, Olvega 42110 (Soria), Spain.
This medicine is distributed in the UK by:
Besins Healthcare (UK) Ltd, Lion Court, 25 Procter Street London, Holborn, United Kingdom
170 mm
| APROBAClON del CLIENTE: CLIENT APPROVAL: | APROBAClON de Cyndea APPROVAL: * PHARMA |
| Fecha: Firma: | Fecha: Firma: |
| Date: Signature: | Date: Signature: |
Utrogestan 200 mg (Vaginal) / REINO UNIDO
| Codigo | Laetus | Version | Fecha | □escripcion de Cambios / Modificaciones | Orden |
| 700841 | 2095 | 01 | 13.05.2020 |
| BESINS |
| 02 | 28.09.2020 |
| BESINS | ||
C’cyndea
PHARMA