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UTROGESTAN VAGINAL 200 MG CAPSULES - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - UTROGESTAN VAGINAL 200 MG CAPSULES

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


X 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 graficos 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


anverso / front


15

mm


10 >! mm I


Altura de barra de pharmacodes (tras corte de papel) Bar height of pharmacodes (after cutting the paper)


12

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Q 11 IB S £


li



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.

  • * Keep this leaflet. 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 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 "

  • 1. What Utrogestan Vaginal is and what it is used for

  • 2. What you need to know before you use Utrogestan Vaginal

  • 3. How to use Utrogestan Vaginal

  • 4. Possible side effects

  • 5. How to store Utrogestan Vaginal

  • 6. Contents of the pack and other information


1. What Utrogestan Vaginal is and what it is used for


E E

o co


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:

  • * 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):

  • – vaginal discharge

  • – vaginal haemorrhage

  • – 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

  • * 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

  • 1. AW en base al previo con cambios indicados por el cliente.

  • 2. Codigo anterior: 700699

BESINS

02

28.09.2020

  • 1. Cambios de texto indicados por el cliente.

  • 2. Tipograffa: Arial 8pt

BESINS

C’cyndea

PHARMA


Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Utrogestan Vaginal 200 mg used for?

Utrogestan Vaginal 200 mg capsules are primarily used for hormone replacement therapy and to treat conditions related to progesterone deficiency, such as irregular menstrual cycles or certain types of infertility.

How do I use Utrogestan Vaginal 200 mg capsules?

For vaginal use, you should insert the capsule deep into the vagina as directed by your healthcare provider, usually at bedtime.

Can I use Utrogestan Vaginal capsules during pregnancy?

Utrogestan is often prescribed during early pregnancy to help sustain the pregnancy in women with a history of miscarriage or hormonal imbalances. Always consult your doctor first.

What are the common side effects of Utrogestan Vaginal?

Common side effects include mild headache, breast tenderness, or nausea. If you experience severe side effects, contact your healthcare provider immediately.

Is Utrogestan safe for long-term use?

Long-term use should be monitored by your healthcare provider to assess benefits and risks, particularly concerning hormonal health.

What should I do if I miss a dose of Utrogestan?

If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue your regular schedule. Don't double up.

Can I take Utrogestan with other medications?

Always inform your doctor about all medications you are taking, including over-the-counter drugs and supplements, to avoid potential interactions.

Does Utrogestan cause weight gain?

Weight changes can occur with hormonal treatments like Utrogestan, but they vary among individuals. Discuss any concerns with your doctor.

Can men take Utrogestan Vaginal capsules?

Utrogestan is not typically prescribed for men; however, it may be used in specific medical situations under close supervision by a healthcare professional.

Is it normal to experience bleeding while using Utrogestan?

Some women may experience light spotting or bleeding when starting treatment; however, if bleeding is heavy or persists, consult your doctor.

How should I store Utrogestan Vaginal capsules?

Store the capsules in a cool, dry place away from direct sunlight and out of reach of children.

Can I use Utrogestan if I have allergies?

If you have allergies to progesterone or any ingredients in Utrogestan, do not use it without consulting your healthcare provider first.

What happens if I take an overdose of Utrogestan?

Overdose symptoms can include severe drowsiness and fatigue. Seek immediate medical attention if you suspect an overdose.

Will using Utrogestan affect my menstrual cycle?

Utrogestan can help regulate menstrual cycles in women with irregular periods due to low progesterone levels; however, individual responses may vary.

Can lifestyle changes enhance the effectiveness of Utrogestan?

Maintaining a healthy lifestyle—balanced diet, regular exercise, and stress management—can enhance overall hormonal balance and treatment effectiveness.

Is there anyone who should avoid using Utrogestan?

Individuals with certain conditions like liver disease or unexplained vaginal bleeding should avoid using Utrogestan unless advised by their healthcare provider.

How long does it take to feel the effects of Utrogestan?

Many patients may begin to notice effects within a few days to weeks; however, full benefits may take longer depending on individual conditions.

Does insurance cover the cost of Utrogestan Vaginal capsules?

Insurance coverage varies by plan; check with your insurance provider regarding coverage for prescription medications like Utrogestan.

Are there any dietary restrictions while taking Utrogestan?

There are no specific dietary restrictions while taking Utrogestan. However, maintaining a balanced diet can support overall health during treatment.

How will I know if Utrogestan is working for me?

Your healthcare provider will monitor your symptoms and hormone levels to determine the effectiveness of the treatment over time.