Active Ingredient and Strength	DROSPIRENONE - 4 MG
Dosage Form	TABLET, FILM COATED
Manufacturer and Country	LABORATORIOS LEÓN FARMA S.A. (PRIMARY PACKAGER) - SPAIN
Registration Number	SIN16354P
Licence Holder	INTEGA PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	G03AC10

4.1 Therapeutic indications

Oral contraception

4.2 Posology and method of administration

Posology

How to take Slinda

One tablet is to be taken daily for 28 consecutive days, one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days. Tablets must be taken every day at about the same time of the day so that the interval between two tablets is always 24 hours. Tablets should be taken in the order shown on the blister. Stickers marked with the 7 days of the week are provided. The woman should choose the sticker that starts with the day she begins taking the tablets and stick it on the blister.

The first tablet of the treatment should be taken on the first day of menstrual bleeding. Thereafter tablet taking is continuous. A subsequent pack is started immediately after finishing the previous pack, without a break in daily tablet intake.

How to start Slinda

No preceding hormonal contraceptive use (in the past month)

Tablet-taking has to start on day 1 of the woman’s natural cycle (first day of her menstrual bleeding). When doing so, no additional contraceptive measures are necessary.

Following first-trimester abortion

After first-trimester abortion it is recommended to start Slinda immediately after abortion took place. In that case there is no need to use an additional contraceptive method.

Following delivery or second-trimester abortion

Contraceptive treatment with Slinda is recommended to start between 21 and 28 days after delivery or second trimester abortion. If contraceptive treatment with Slinda is initiated later but before the menstruations have returned, pregnancy must be ruled out and an additional method of contraception should be used for the first week.

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

Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch)

The woman should start Slinda preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch. In these cases, the use of an additional contraceptive is not necessary.

The woman may also start Slinda at the latest on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet taking an additional barrier method is recommended.

Changing from a progestogen-only-method (progestogen-only pill (POP), injection, implant) or from a progestogen-releasing intrauterine system (IUS)

The woman may switch any day from other POP and should start Slinda the day after, within 24 hours of discontinuing the previous POP. A woman may switch form an Implant or following IUS removal on the same day that the implant or IUS is removed. A woman may switch from using an injectable contraceptive and should start Slinda on the day the next injection was due to occur.

Management of missed tablets

The management of missed tablets can be guided by the following two basic rules:

Seven days of uninterrupted taking of active tablets is required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis. Active tablet-taking must never be discontinued for longer than 7 days.
The greater the number of white active tablets that are missed, and the closer they are to the green placebo tablets, the higher the risk of a pregnancy.

If the patient is less than 24 hours late in taking any white active tablet, contraceptive protection is not reduced. The patient should take the tablet as soon as they remember and should take further tablets at the usual time.

If the patient is more than 24 hours late in taking any white active tablet, contraceptive protection may be reduced.

The following advice can be given if a white active tablet is missed during:

Day 1–7

The patient should take the last missed white active tablet as soon as they remember, even if this means taking two tablets at the same time. The patient should then continue to take tablets at the usual time.

In addition, a barrier method such as a condom should be used until they have completed 7 days of uninterrupted white active table-taking.

If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered.

Days 8–17

The patient should take the last missed tablet as soon as they remember, even if this means taking two tablets at the same time. The patient should then continue to take tablets at the usual time.

Provided that the patient has taken the active tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. However, if they have missed more than 1 tablet, they should be advised to use extra precautions until they have completed 7 days of uninterrupted white active tablet-taking.

Days 18–24

Contraceptive reliability is reduced. Contraceptive protection can still be provided, by adhering to either of the following two options:

The patient should take the last missed tablet as soon as they remember, even if this means taking two tablets at the same time. They then continue to take tablets at the usual time until the white active tablets are used up. The 4 green placebo tablets from the last row should be discarded, and the next blister pack started straight away. The patient is unlikely to have a withdrawal bleed until the end of the active tablets section of the second pack, but they may experience spotting or breakthrough bleeding on active tablet-taking days.
Alternatively, the patient may be advised to discontinue active tablet- taking from the current blister pack. They should immediately commence taking the green placebo tablets for a maximum of 3 days, such that the total number of green placebo tablets plus missed active white tablets is not more than 4. The patient should subsequently commence taking active white tablets from a new blister pack.

Provided that in the 7 days preceding the first missed tablet the patient has taken all tablets correctly, there is no need to use extra contraceptive precautions.

If the patient has missed a tablet during the preceding 7 days, then the patient should use extra contraceptive precautions for the next 7 days and follow option a) above.

If the patient missed tablets and subsequently has no withdrawal bleed in the placebo tablet interval, the possibility of a pregnancy should be considered.

Please note: If the patient is not sure about the number or colour of tablets missed and what advice to follow, a barrier method should be used until they have completed 7 days of uninterrupted white active tablet-taking.

Green placebo tablets missed

Contraceptive protection is not reduced. Green tablets from the last (4th) row of the blister can be disregarded. However, the missed tablets should be discarded to avoid unintentionally prolonging the placebo tablet phase.

Advice in case of gastrointestinal disturbances

In case of severe gastrointestinal disturbances (e.g., vomiting or diarrhoea), absorption may not be complete and additional contraceptive measures should be taken.
If vomiting or diarrhoea 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. If the woman does not want to change their normal tablet-taking schedule, she has to take the extra tablet(s) from another blister pack.

Paediatric population

Safety and efficacy of Slinda have been established in women of reproductive age. Safety and efficacy are expected to be the same for post pubertal adolescents under the age of 18 and users 18 years and older. Use of this product before menarche is not indicated.

Method of administration

For oral use.

4.3 Contraindications

Progestogen-only contraceptives (POCs) like Slinda 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 Slinda use, the medicinal product should be discontinued immediately.

Active venous thromboembolic disorder.
Presence or history of severe hepatic disease as long as liver function values have not returned to normal, such as liver tumors, benign or malignant, or hepatic impairment.
Severe renal insufficiency, acute renal failure and renal impairment.
Known or suspected sex-steroid sensitive malignancies.
Undiagnosed vaginal bleeding.
Hypersensitivity to the active substance 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.