GVEZA FILM COATED TABLETS 3MG/ 0.03MG [SIN14996P]

Product Info

GVEZA FILM COATED TABLETS 3MG/ 0.03MG

[SIN14996P]

4.1 Therapeutic indications

Oral contraception.

4.2 Posology and method of administration

Posology

How to take GVEZA
The tablets must be taken every day at about the same time, if necessary with a little liquid, in the order shown on the blister pack. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2–3 after the last tablet and may not have finished before the next pack is started.

How to start GVEZA
No preceding hormonal contraceptive use (in the past month)

Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2–5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking.

• Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)
  The woman should start with GVEZA preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start using GVEZA preferably on the day of removal, but at the latest when the next application would have been due.

• Changing from a progestogen-only-method (progestogen-only pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS)
  The woman may switch any day from the progestogen-only pill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but should in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet taking.

• Following first-trimester abortion
  The woman may start immediately. When doing so, she need not take additional contraceptive measures.

• Following delivery or second-trimester abortion
  Women should be advised to start at day 21 to 28 after delivery or second-trimester abortion. When starting later, the woman should be advised to additionally use a barrier method for the first 7 days. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her first menstrual period.

For breastfeeding women, see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

Management of missed tablets
If the user is less than 12 hours late in taking any tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.

If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:

1. Tablet-taking must never be discontinued for longer than 7 days.

2. 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.

Accordingly the following advice can be given in daily practice:

• Week 1
  The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. In addition, a barrier method such as a condom should be used for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the regular tablet-free interval, the higher the risk of a pregnancy.

• Week 2
  The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. However, if this is not the case, or if she has missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days.

• Week 3
  The risk of reduced reliability is imminent because of the forthcoming 7 day tablet-free interval. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented. By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly. If this is not the case, she should follow the first of these two options and use extra precautions for the next 7 days as well.

  1. The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. The next blister pack must be started as soon as the current blister pack is finished, i.e., no gap should be left between packs. The user is unlikely to have a withdrawal bleed until the end of the second pack, but she may experience spotting or breakthrough bleeding on tablettaking days.

  2. The woman may also be advised to discontinue tablet-taking from the current blister pack. She should then have a tablet-free interval of up to 7 days, including the days she missed tablets, and subsequently continue with the next blister pack.

If the woman missed tablets and subsequently has no withdrawal bleed in the first normal tablet-free interval, the possibility of a pregnancy should be considered.

Advice in case of gastro-intestinal disturbances
In case of severe gastro-intestinal disturbances (e.g. vomiting or diarrhoea), absorption may not be complete and additional contraceptive measures should be taken.

If vomiting occurs within 3–4 hours after tablet taking, a new (replacement) tablet should be taken as soon as possible. The new tablet should be taken within 12 hours of the usual time of tablet-taking if possible. If more than 12 hours elapse, the advice concerning missed tablets, as given in section 4.2 “Management of missed tablets”, is applicable – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) from another blister pack.

How to postpone a withdrawal bleed
To delay a period the woman should continue with another blister pack of GVEZA without a tablet-free interval. The extension can be carried on for as long as wished until the end of the second pack. During the extension the woman may experience breakthrough-bleeding or spotting. Regular intake of GVEZA is then resumed after the usual 7-day tablet-free interval.

To shift her periods to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming tablet-free interval by as many days as she likes. The shorter the interval, the higher the risk that she does not have a withdrawal bleed and will experience breakthrough-bleeding and spotting during the subsequent pack (just as when delaying a period).

Additional information on special populations
Children and adolescents
GVEZA is only indicated after menarche. There are no data suggesting the need for a dosage adjustment.

Geriatric patients
Not applicable. GVEZA is not indicated after menopause.

Patients with hepatic impairment
GVEZA is contraindicated in women with severe hepatic diseases. See also sections ‘Contraindications’ and ‘Pharmacokinetic properties’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Patients with renal impairment
GVEZA is contraindicated in women with severe renal insufficiency or acute renal failure. See also sections ‘Contraindications’ and ‘Pharmacokinetic properties’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of administration
Oral use.

4.3 Contraindications

Combined oral contraceptives (COCs) should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during COC use, the product should be stopped immediately.

• Presence or risk of venous thromboembolism (VTE)

  • Venous thromboembolism – current VTE (on anticoagulants) or history of deep venous thrombosis [DVT] or pulmonary embolism [PE]

  • Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency

  • Major surgery with prolonged immobilization (see under “Special Warnings and Special Precautions for Use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

  • A high risk of venous thromboembolism due to the presence of multiple risk factors

• Presence or risk of arterial thromboembolism (ATE)

  • Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris)

  • Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA)

  • Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia, and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)

  • History of migraine with focal neurological symptoms

  • A high risk of arterial thromboembolism due to multiple risk factors (see under “Special Warnings and Special Precautions for Use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) or to the presence of one serious risk factor such as:

    • Diabetes mellitus with vascular symptoms

    • Severe hypertension

    • Severe dyslipoproteinaemia

• Pancreatitis, or a history thereof, if associated with severe hypertriglyceridaemia.

• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

• Renal Impairment.

• Presence or history of liver tumours (benign or malignant).

• Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts).

• Undiagnosed vaginal bleeding.

• Cholestatic jaundice or pregnancy or jaundice with prior pill use.

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.